<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03834168</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002114</org_study_id>
    <nct_id>NCT03834168</nct_id>
  </id_info>
  <brief_title>The Diurnal Rhythm in Natriuretic Peptide Levels</brief_title>
  <official_title>The Diurnal Rhythm in Natriuretic Peptide Levels and Relationship With Nocturnal Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its&#xD;
      temporal relationship with nocturnal blood pressure in obese and African-American individuals&#xD;
      as compared with lean and white individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obese and African-American individuals are at greater risk for cardiovascular morbidity and&#xD;
      mortality than lean and white individuals. One of the key reasons for this health disparity&#xD;
      is a higher risk of hypertension among obese and African-American individuals. The reasons&#xD;
      for why these disparities develop are not well understood.&#xD;
&#xD;
      Natriuretic peptides are hormones produced by the heart and have a wide range of favorable&#xD;
      cardiovascular effects such as natriuresis (sodium excretion), vasodilation, and direct&#xD;
      inhibition of the renin-angiotensin-aldosterone system. Human studies showed the existence of&#xD;
      24-hour (diurnal) variations in the circulating natriuretic peptide levels.&#xD;
&#xD;
      Prior work from the investigators and others demonstrated that individuals with&#xD;
      genetically-determined lower circulating natriuretic peptides levels have higher blood&#xD;
      pressure and greater risk of hypertension. Further, the investigators have shown that obesity&#xD;
      and African-American race are associated with lower natriuretic peptide levels, suggesting&#xD;
      that relatively low natriuretic peptide levels may be a biologic determinant contributing to&#xD;
      health disparities.&#xD;
&#xD;
      Obese and African-American individuals have a greater prevalence of nocturnal hypertension&#xD;
      [nighttime blood pressure &gt;120/80 mmHg], which is an independent risk factor for&#xD;
      cardiovascular events. The underlying reasons for 24-hour variations in blood pressure are&#xD;
      unknown.&#xD;
&#xD;
      The investigators hypothesize that loss of the natural 24-hour rhythm of natriuretic peptide&#xD;
      levels plays a role in the development of nocturnal hypertension in obese and&#xD;
      African-American individuals. The aims of this study are:&#xD;
&#xD;
        1. to examine whether there is a presence of a 24-hour rhythm in natriuretic peptide levels&#xD;
           among normotensive obese and African-American individuals and whether there is a&#xD;
           difference in the rhythmicity of natriuretic peptide levels between obese and lean as&#xD;
           well as in African-Americans and whites;&#xD;
&#xD;
        2. to examine whether there is an existence of a relationship between 24-hour variability&#xD;
           of natriuretic peptide levels and 24-hour patterns of blood pressure and whether this&#xD;
           relationship of rhythmicity of natriuretic peptide levels and nocturnal blood pressure&#xD;
           differed in obese and lean individuals and by race.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma MRproANP</measure>
    <time_frame>About 24 hours on the in-patient study visit day after consuming study meals for 5 days</time_frame>
    <description>Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm</measure>
    <time_frame>About 24 hours on the in-patient study visit day after consuming study meals for 5 days</time_frame>
    <description>Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Plasma MRproANP</measure>
    <time_frame>About 24 hours on the in-patient study visit day after consuming study meals for 5 days</time_frame>
    <description>Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Natriuretic Peptides</condition>
  <condition>Obesity</condition>
  <condition>Nocturnal Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Study Individuals</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy self-identified African-American and white male participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standardized Study Diet</intervention_name>
    <description>Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
    <arm_group_label>Study Individuals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 40 years&#xD;
&#xD;
          -  Blood pressure less than 140/90&#xD;
&#xD;
          -  Body Mass Index between 18.5 to 25 kg/m2 (lean) or 30 to 45 kg/m2 (obese)&#xD;
&#xD;
          -  Self identified African-American or white individuals&#xD;
&#xD;
          -  Willingness to comply with the study diet&#xD;
&#xD;
          -  Provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypertension&#xD;
&#xD;
          -  History of cardiovascular, renal, or liver disease&#xD;
&#xD;
          -  Diabetes or use of glucose-lowering medications&#xD;
&#xD;
          -  Use of vasoactive or diuretic medications&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Anemia (Hematocrit &lt;41%)&#xD;
&#xD;
          -  Abnormal serum sodium or potassium&#xD;
&#xD;
          -  Abnormal liver function tests (&gt;3x upper limit of normal)&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Regular users of non-steroid anti-inflammatory medications&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pankaj Arora, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Orlando M Gutierrez, MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Goetze JP, Jorgensen HL, Sennels HP, Fahrenkrug J. Diurnal plasma concentrations of natriuretic propeptides in healthy young males. Clin Chem. 2012 Apr;58(4):789-92. doi: 10.1373/clinchem.2011.178921. Epub 2012 Jan 26. No abstract available.</citation>
    <PMID>22282468</PMID>
  </reference>
  <reference>
    <citation>Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265.</citation>
    <PMID>25595796</PMID>
  </reference>
  <reference>
    <citation>Bajaj NS, Gutierrez OM, Arora G, Judd SE, Patel N, Bennett A, Prabhu SD, Howard G, Howard VJ, Cushman M, Arora P. Racial Differences in Plasma Levels of N-Terminal Pro-B-Type Natriuretic Peptide and Outcomes: The Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study. JAMA Cardiol. 2018 Jan 1;3(1):11-17. doi: 10.1001/jamacardio.2017.4207.</citation>
    <PMID>29167879</PMID>
  </reference>
  <reference>
    <citation>Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049.</citation>
    <PMID>26892417</PMID>
  </reference>
  <results_reference>
    <citation>Parcha V, Patel N, Gutierrez OM, Li P, Gamble KL, Musunuru K, Margulies KB, Cappola TP, Wang TJ, Arora G, Arora P. Chronobiology of Natriuretic Peptides and Blood Pressure in Lean and Obese Individuals. J Am Coll Cardiol. 2021 May 11;77(18):2291-2303. doi: 10.1016/j.jacc.2021.03.291.</citation>
    <PMID>33958126</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <results_first_submitted>May 28, 2021</results_first_submitted>
  <results_first_submitted_qc>August 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2021</results_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Pankaj Arora, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Diurnal Rhythm</keyword>
  <keyword>Race</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03834168/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03834168/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 42 participants agreed to participate in the study following the completion of the informed consent process and were assigned to each Arm/group. We had one study dropout and one participant was not able to complete the protocol. A total of 40 participants completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lean</title>
          <description>Healthy self-identified African-American and white male lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
        </group>
        <group group_id="P2">
          <title>Obese</title>
          <description>Healthy self-identified African-American and white male obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Total Participant Screened for the Purpose of Eligibility</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Ineligible Participants</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Unable to Complete the Protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Study Dropouts</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Received 5 Days of Standardized Meals</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Returned for the 24-h Inpatient Protocol</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lean</title>
          <description>Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
        </group>
        <group group_id="B2">
          <title>Obese</title>
          <description>Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.5" lower_limit="24.0" upper_limit="32.0"/>
                    <measurement group_id="B2" value="33.0" lower_limit="26.0" upper_limit="37.0"/>
                    <measurement group_id="B3" value="31.0" lower_limit="26.0" upper_limit="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.3" lower_limit="21.9" upper_limit="25.0"/>
                    <measurement group_id="B2" value="32.2" lower_limit="30.7" upper_limit="36.0"/>
                    <measurement group_id="B3" value="29.6" lower_limit="24.4" upper_limit="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hip circumference</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97.3" lower_limit="93.8" upper_limit="101.0"/>
                    <measurement group_id="B2" value="111.4" lower_limit="106.1" upper_limit="118.7"/>
                    <measurement group_id="B3" value="106.1" lower_limit="96.1" upper_limit="114.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist circumference</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.9" lower_limit="73.5" upper_limit="85.7"/>
                    <measurement group_id="B2" value="103.6" lower_limit="99.8" upper_limit="111.8"/>
                    <measurement group_id="B3" value="97.6" lower_limit="78.3" upper_limit="105.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110.7" lower_limit="102.0" upper_limit="122.7"/>
                    <measurement group_id="B2" value="116.5" lower_limit="108.3" upper_limit="126.0"/>
                    <measurement group_id="B3" value="116.2" lower_limit="106.0" upper_limit="123.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.5" lower_limit="64.3" upper_limit="76.0"/>
                    <measurement group_id="B2" value="73.7" lower_limit="67.7" upper_limit="80.0"/>
                    <measurement group_id="B3" value="71.0" lower_limit="65.3" upper_limit="78.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart rate</title>
          <units>beats/min</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.5" lower_limit="66.0" upper_limit="80.0"/>
                    <measurement group_id="B2" value="77.0" lower_limit="71.0" upper_limit="80.0"/>
                    <measurement group_id="B3" value="77.0" lower_limit="69.0" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting Glucose</title>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85.0" lower_limit="79.0" upper_limit="96.0"/>
                    <measurement group_id="B2" value="91.5" lower_limit="82.0" upper_limit="100.0"/>
                    <measurement group_id="B3" value="87.5" lower_limit="81.0" upper_limit="97.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Renal Function</title>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Blood Urea Nitrogen (BUN)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.0" lower_limit="11.0" upper_limit="13.0"/>
                    <measurement group_id="B2" value="12.0" lower_limit="10.0" upper_limit="14.0"/>
                    <measurement group_id="B3" value="12" lower_limit="10.5" upper_limit="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Creatinine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.9" lower_limit="0.8" upper_limit="0.9"/>
                    <measurement group_id="B2" value="0.9" lower_limit="0.8" upper_limit="1.0"/>
                    <measurement group_id="B3" value="0.9" lower_limit="0.8" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Electrolytes</title>
          <units>mEq/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Sodium, mEq/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137.5" lower_limit="137.0" upper_limit="139.0"/>
                    <measurement group_id="B2" value="138.0" lower_limit="136.0" upper_limit="138.0"/>
                    <measurement group_id="B3" value="138.0" lower_limit="136.5" upper_limit="138.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, mEq/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.2" lower_limit="3.9" upper_limit="4.3"/>
                    <measurement group_id="B2" value="4.2" lower_limit="4.0" upper_limit="4.3"/>
                    <measurement group_id="B3" value="4.2" lower_limit="3.9" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, mEq/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102.5" lower_limit="102.0" upper_limit="104.0"/>
                    <measurement group_id="B2" value="103.5" lower_limit="102.0" upper_limit="105.0"/>
                    <measurement group_id="B3" value="103.0" lower_limit="102.0" upper_limit="104.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate, mEq/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.0" lower_limit="25.0" upper_limit="28.0"/>
                    <measurement group_id="B2" value="26.0" lower_limit="25.0" upper_limit="27.0"/>
                    <measurement group_id="B3" value="26.0" lower_limit="25.0" upper_limit="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Calcium</title>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.6" lower_limit="9.3" upper_limit="9.7"/>
                    <measurement group_id="B2" value="9.6" lower_limit="9.2" upper_limit="9.8"/>
                    <measurement group_id="B3" value="9.6" lower_limit="9.3" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver Function</title>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Total bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.5" lower_limit="0.4" upper_limit="0.8"/>
                    <measurement group_id="B2" value="0.5" lower_limit="0.4" upper_limit="0.7"/>
                    <measurement group_id="B3" value="0.5" lower_limit="0.4" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine transaminase (ALT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" lower_limit="11.0" upper_limit="16.0"/>
                    <measurement group_id="B2" value="17.0" lower_limit="12.0" upper_limit="27.0"/>
                    <measurement group_id="B3" value="14.0" lower_limit="12.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate transaminase (AST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.0" lower_limit="14.0" upper_limit="20.0"/>
                    <measurement group_id="B2" value="17.0" lower_limit="14.0" upper_limit="23.0"/>
                    <measurement group_id="B3" value="17.0" lower_limit="14.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma-glutamyl transferase (GGT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.0" lower_limit="12.0" upper_limit="24.0"/>
                    <measurement group_id="B2" value="22.5" lower_limit="15.0" upper_limit="27.0"/>
                    <measurement group_id="B3" value="20.0" lower_limit="12.5" upper_limit="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematological Parameters</title>
          <units>cells*10,000/mm^3</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>WBC, * 10,000/mm3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.3" lower_limit="4.3" upper_limit="6.7"/>
                    <measurement group_id="B2" value="5.5" lower_limit="4.6" upper_limit="6.1"/>
                    <measurement group_id="B3" value="5.4" lower_limit="4.4" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RBC, * 1,000,000/mm3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.7" lower_limit="4.1" upper_limit="5.0"/>
                    <measurement group_id="B2" value="4.7" lower_limit="4.1" upper_limit="5.0"/>
                    <measurement group_id="B3" value="4.7" lower_limit="4.1" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet, * 100,000/mm3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="217.7" lower_limit="192.8" upper_limit="274.9"/>
                    <measurement group_id="B2" value="248.7" lower_limit="223.6" upper_limit="268.2"/>
                    <measurement group_id="B3" value="243.4" lower_limit="202.2" upper_limit="271.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin</title>
          <units>g/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.0" lower_limit="13.1" upper_limit="14.9"/>
                    <measurement group_id="B2" value="14.2" lower_limit="13.2" upper_limit="14.8"/>
                    <measurement group_id="B3" value="14.2" lower_limit="13.2" upper_limit="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematocrit</title>
          <units>%</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.5" lower_limit="37.0" upper_limit="43.0"/>
                    <measurement group_id="B2" value="41.0" lower_limit="38.0" upper_limit="43.0"/>
                    <measurement group_id="B3" value="41.0" lower_limit="37.5" upper_limit="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Corpuscular Volume (MCV)</title>
          <units>fl</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87.5" lower_limit="84.0" upper_limit="90.0"/>
                    <measurement group_id="B2" value="89.0" lower_limit="86.0" upper_limit="92.0"/>
                    <measurement group_id="B3" value="88.0" lower_limit="86.0" upper_limit="91.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Corpuscular Hemoglobin (MCH)</title>
          <units>pg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.0" lower_limit="29.0" upper_limit="31.0"/>
                    <measurement group_id="B2" value="31.0" lower_limit="29.0" upper_limit="32.0"/>
                    <measurement group_id="B3" value="30.0" lower_limit="29.0" upper_limit="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Corpuscular Hemoglobin Concentration (MCHC)</title>
          <units>g/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.0" lower_limit="33.0" upper_limit="34.0"/>
                    <measurement group_id="B2" value="34.0" lower_limit="33.0" upper_limit="35.0"/>
                    <measurement group_id="B3" value="34.0" lower_limit="33.0" upper_limit="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Red Cell Distribution Width (RDW)</title>
          <units>%</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" lower_limit="13.1" upper_limit="13.9"/>
                    <measurement group_id="B2" value="13.3" lower_limit="12.8" upper_limit="14.5"/>
                    <measurement group_id="B3" value="13.5" lower_limit="12.8" upper_limit="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Platelet Volume (MPV)</title>
          <units>fL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.0" lower_limit="8.0" upper_limit="9.0"/>
                    <measurement group_id="B2" value="8.0" lower_limit="8.0" upper_limit="9.0"/>
                    <measurement group_id="B3" value="9.0" lower_limit="8.0" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plasma MRproANP</title>
        <description>Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals</description>
        <time_frame>About 24 hours on the in-patient study visit day after consuming study meals for 5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lean</title>
            <description>Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Obese</title>
            <description>Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma MRproANP</title>
          <description>Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals</description>
          <units>pmol/l</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.92" lower_limit="12.94" upper_limit="25.21"/>
                    <measurement group_id="O2" value="15.51" lower_limit="10.61" upper_limit="22.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Regression (Cosinor Fit)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm</title>
        <description>Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race</description>
        <time_frame>About 24 hours on the in-patient study visit day after consuming study meals for 5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lean</title>
            <description>Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Obese</title>
            <description>Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm</title>
          <description>Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race</description>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.03"/>
                    <measurement group_id="O2" value="-4.9" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Plasma MRproANP</title>
        <description>Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals</description>
        <time_frame>About 24 hours on the in-patient study visit day after consuming study meals for 5 days</time_frame>
        <posting_date>08/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lean</title>
          <description>Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
        </group>
        <group group_id="E2">
          <title>Obese</title>
          <description>Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).&#xD;
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Pankaj Arora</name_or_title>
      <organization>UNIVERSITY OF ALABAMA AT BIRMINGHAM</organization>
      <phone>2059754720</phone>
      <email>parora@uabmc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03834168
org study id: IRB-300002114
nct id: NCT03834168
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its
      temporal relationship with nocturnal blood pressure in obese and African-American individuals
      as compared with lean and white individuals.
Obese and African-American individuals are at greater risk for cardiovascular morbidity and
      mortality than lean and white individuals. One of the key reasons for this health disparity
      is a higher risk of hypertension among obese and African-American individuals. The reasons
      for why these disparities develop are not well understood.

      Natriuretic peptides are hormones produced by the heart and have a wide range of favorable
      cardiovascular effects such as natriuresis (sodium excretion), vasodilation, and direct
      inhibition of the renin-angiotensin-aldosterone system. Human studies showed the existence of
      24-hour (diurnal) variations in the circulating natriuretic peptide levels.

      Prior work from the investigators and others demonstrated that individuals with
      genetically-determined lower circulating natriuretic peptides levels have higher blood
      pressure and greater risk of hypertension. Further, the investigators have shown that obesity
      and African-American race are associated with lower natriuretic peptide levels, suggesting
      that relatively low natriuretic peptide levels may be a biologic determinant contributing to
      health disparities.

      Obese and African-American individuals have a greater prevalence of nocturnal hypertension
      [nighttime blood pressure >120/80 mmHg], which is an independent risk factor for
      cardiovascular events. The underlying reasons for 24-hour variations in blood pressure are
      unknown.

      The investigators hypothesize that loss of the natural 24-hour rhythm of natriuretic peptide
      levels plays a role in the development of nocturnal hypertension in obese and
      African-American individuals. The aims of this study are:

        1. to examine whether there is a presence of a 24-hour rhythm in natriuretic peptide levels
           among normotensive obese and African-American individuals and whether there is a
           difference in the rhythmicity of natriuretic peptide levels between obese and lean as
           well as in African-Americans and whites;

        2. to examine whether there is an existence of a relationship between 24-hour variability
           of natriuretic peptide levels and 24-hour patterns of blood pressure and whether this
           relationship of rhythmicity of natriuretic peptide levels and nocturnal blood pressure
           differed in obese and lean individuals and by race.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Plasma MRproANP
time frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days
description: Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals
measure: Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm
time frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days
description: Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race
measure: Plasma MRproANP
time frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days
description: Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals
arm group label: Study Individuals
arm group type: Other
description: Healthy self-identified African-American and white male participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
intervention type: Other
intervention name: standardized Study Diet
description: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
arm group label: Study Individuals
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pankaj Arora, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Orlando M Gutierrez, MMSc
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
citation: Goetze JP, Jorgensen HL, Sennels HP, Fahrenkrug J. Diurnal plasma concentrations of natriuretic propeptides in healthy young males. Clin Chem. 2012 Apr;58(4):789-92. doi: 10.1373/clinchem.2011.178921. Epub 2012 Jan 26. No abstract available.
PMID: 22282468
citation: Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265.
PMID: 25595796
citation: Bajaj NS, Gutierrez OM, Arora G, Judd SE, Patel N, Bennett A, Prabhu SD, Howard G, Howard VJ, Cushman M, Arora P. Racial Differences in Plasma Levels of N-Terminal Pro-B-Type Natriuretic Peptide and Outcomes: The Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study. JAMA Cardiol. 2018 Jan 1;3(1):11-17. doi: 10.1001/jamacardio.2017.4207.
PMID: 29167879
citation: Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049.
PMID: 26892417
citation: Parcha V, Patel N, Gutierrez OM, Li P, Gamble KL, Musunuru K, Margulies KB, Cappola TP, Wang TJ, Arora G, Arora P. Chronobiology of Natriuretic Peptides and Blood Pressure in Lean and Obese Individuals. J Am Coll Cardiol. 2021 May 11;77(18):2291-2303. doi: 10.1016/j.jacc.2021.03.291.
PMID: 33958126
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Pankaj Arora, MD
investigator title: Assistant Professor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 