<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/NCT01709123</url>
  </required_header>
  <id_info>
    <org_study_id>H-08-028</org_study_id>
    <secondary_id>3R01DK072433-03S1</secondary_id>
    <nct_id>NCT01709123</nct_id>
  </id_info>
  <brief_title>Effects of Micronutrient (Chromium) Supplementation on Diabetes</brief_title>
  <official_title>Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center Shreveport</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Louisiana State University Health Sciences Center Shreveport</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the&#xD;
      devastating complications that result from poorly controlled diabetes. However, for many&#xD;
      patients, achievement of tight glucose control is difficult with current regimens. Trivalent&#xD;
      chromium, the form found in foods and dietary supplements, is believed to be safe. Our&#xD;
      preliminary studies have reported that chromium supplementation inhibits the increase in&#xD;
      pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and&#xD;
      IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly,&#xD;
      animal studies have shown that chromium niacinate supplementation lowered blood levels of&#xD;
      glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines&#xD;
      are proteins that are secreted by monocytes and other cells in response to various stimuli,&#xD;
      such as infection. Some of the cytokines are known to regulate insulin sensitivity and&#xD;
      elevated level of these cytokines in blood may accelerate clogging of arteries. Thus,&#xD;
      chromium supplementation may increase insulin sensitivity and glycemic control in diabetic&#xD;
      patients, and may prevent the development of cardiovascular disease in diabetic patients.&#xD;
      Given the enormous public health cost of diabetes, the prospect of being able to use a&#xD;
      relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in&#xD;
      achieving normal blood glucose level merits further study.&#xD;
&#xD;
      We will examine the effects of placebo and chromium niacinate supplementation on the fasting&#xD;
      glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic&#xD;
      patients. We will determine these above parameters at baseline and after the 1, 2 and 3&#xD;
      months of supplementation in diabetic patients. The long-term objective is to explore the&#xD;
      efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the&#xD;
      development of cardiovascular disease (CVD), and improve the life expectancy in diabetic&#xD;
      population.&#xD;
&#xD;
      Chromium supplements are widely used by the public and are available in many stores, such as&#xD;
      Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace&#xD;
      metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an&#xD;
      essential vitamin for our body. This study plans to use chromium niacinate, a complex of&#xD;
      chromium and niacin. Chromium niacinate is considered a nutrient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2007</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Glucose Level</measure>
    <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
    <description>Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Glucose Levels</measure>
    <time_frame>Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.</time_frame>
    <description>Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipid Levels</measure>
    <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
    <description>Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Levels of Cytokines/Inflammatory Biomarkers</measure>
    <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
    <description>Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Levels of Cytokines/Inflammatory Biomarkers</measure>
    <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
    <description>Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Levels of Cytokines/Inflammatory Biomarkers</measure>
    <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
    <description>Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Levels of Cytokines/Inflammatory Biomarkers</measure>
    <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
    <description>Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chromium niacinate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chromium niacinate</intervention_name>
    <description>200ug or 500ug supplementation in pill form</description>
    <arm_group_label>chromium niacinate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo pill for chromium niacinate</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Type 1 diabetes mellitus&#xD;
&#xD;
          -  Participants between the ages of 8 and 21&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with sickle cell disease, renal or liver disease&#xD;
&#xD;
          -  Serum positive pregnancy test or breastfeeding&#xD;
&#xD;
          -  Participants unwilling/unable to take supplements in pill form&#xD;
&#xD;
          -  Participants taking prescription medication or supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sushil K Jain, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louisiana State University Health Sciences Center in Shreveport</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Louisiana State University Health Sciences Center in Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>September 7, 2021</results_first_submitted>
  <results_first_submitted_qc>June 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 30, 2022</results_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus, Juvenile Onset</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Hyperglycemia</keyword>
  <keyword>Hyperketonemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
        </group>
        <group group_id="P2">
          <title>Chromium Niacinate</title>
          <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The original number of enrolled participants was 62. 18 participants withdrew from the study, leaving 44 participants to remain, with 22 participants in each category.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
        </group>
        <group group_id="B2">
          <title>Chromium Niacinate</title>
          <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</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="22"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="44"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Glucose Level</title>
        <description>Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.</description>
        <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
          </group>
          <group group_id="O2">
            <title>Chromium Niacinate</title>
            <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Glucose Level</title>
          <description>Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Figures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172.39" spread="20.641"/>
                    <measurement group_id="O2" value="212.85" spread="21.153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Figures:16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.47" spread="16.187"/>
                    <measurement group_id="O2" value="191.25" spread="21.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Blood Glucose Levels</title>
        <description>Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.</description>
        <time_frame>Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
          </group>
          <group group_id="O2">
            <title>Chromium Niacinate</title>
            <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Glucose Levels</title>
          <description>Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.</description>
          <units>mmol/mol</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Figures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5667" spread="0.4708"/>
                    <measurement group_id="O2" value="9.7368" spread="0.4888"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Figures: 16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2267" spread="0.4396"/>
                    <measurement group_id="O2" value="9.5606" spread="0.4839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lipid Levels</title>
        <description>Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.</description>
        <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
          </group>
          <group group_id="O2">
            <title>Chromium Niacinate</title>
            <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
          </group>
        </group_list>
        <measure>
          <title>Lipid Levels</title>
          <description>Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Cholesterol values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165.50" spread="10.095"/>
                    <measurement group_id="O2" value="160.42" spread="7.1301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol values:16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.87" spread="7.6000"/>
                    <measurement group_id="O2" value="164.78" spread="9.1092"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline HDL values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.944" spread="2.7871"/>
                    <measurement group_id="O2" value="53.842" spread="3.1122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL values:16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.733" spread="2.6806"/>
                    <measurement group_id="O2" value="54.889" spread="3.1425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline LDL values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.000" spread="7.7147"/>
                    <measurement group_id="O2" value="87.579" spread="5.5442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL values:16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.867" spread="7.2170"/>
                    <measurement group_id="O2" value="93.556" spread="6.4409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline triglyceride values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.333" spread="10.538"/>
                    <measurement group_id="O2" value="91.105" spread="13.914"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglyceride values:16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.200" spread="6.0688"/>
                    <measurement group_id="O2" value="81.722" spread="14.557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
        <description>Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group.</description>
        <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
          </group>
          <group group_id="O2">
            <title>Chromium Niacinate</title>
            <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
          <description>Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group.</description>
          <units>mean fluorescent unit</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ROS values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53587.3" spread="1471.25"/>
                    <measurement group_id="O2" value="51877.2" spread="977.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ROS values:16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56864.8" spread="1474.31"/>
                    <measurement group_id="O2" value="53577.0" spread="2970.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
        <description>Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group.</description>
        <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
          </group>
          <group group_id="O2">
            <title>Chromium Niacinate</title>
            <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
          <description>Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group.</description>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Interleukin-6 Values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6795" spread="0.1801"/>
                    <measurement group_id="O2" value="1.7754" spread="0.1848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interleukin-6 Values: 16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0290" spread="0.4057"/>
                    <measurement group_id="O2" value="2.0000" spread="0.3527"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
        <description>Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group.</description>
        <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
          </group>
          <group group_id="O2">
            <title>Chromium Niacinate</title>
            <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
          <description>Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group.</description>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline CRP values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185.20" spread="9.8926"/>
                    <measurement group_id="O2" value="186.48" spread="7.6407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRP values: 16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.98" spread="9.5580"/>
                    <measurement group_id="O2" value="185.11" spread="8.6807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
        <description>Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group.</description>
        <time_frame>Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
          </group>
          <group group_id="O2">
            <title>Chromium Niacinate</title>
            <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Levels of Cytokines/Inflammatory Biomarkers</title>
          <description>Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group.</description>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Leptin values</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.715" spread="4.2746"/>
                    <measurement group_id="O2" value="16.263" spread="3.3631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leptin: 16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.885" spread="4.1824"/>
                    <measurement group_id="O2" value="14.776" spread="3.1102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.&#xD;
placebo: Placebo pill for chromium niacinate</description>
        </group>
        <group group_id="E2">
          <title>Chromium Niacinate</title>
          <description>Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period&#xD;
chromium niacinate: 200ug or 500ug supplementation in pill form</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="22"/>
                <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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="22"/>
                <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>Sushil K. Jain, PhD</name_or_title>
      <organization>Louisiana State University Health Science Shreveport</organization>
      <phone>318.675.6086</phone>
      <email>sushil.jain@lsuhs.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/NCT01709123
org study id: H-08-028
secondary id: 3R01DK072433-03S1
nct id: NCT01709123
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the
      devastating complications that result from poorly controlled diabetes. However, for many
      patients, achievement of tight glucose control is difficult with current regimens. Trivalent
      chromium, the form found in foods and dietary supplements, is believed to be safe. Our
      preliminary studies have reported that chromium supplementation inhibits the increase in
      pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and
      IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly,
      animal studies have shown that chromium niacinate supplementation lowered blood levels of
      glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines
      are proteins that are secreted by monocytes and other cells in response to various stimuli,
      such as infection. Some of the cytokines are known to regulate insulin sensitivity and
      elevated level of these cytokines in blood may accelerate clogging of arteries. Thus,
      chromium supplementation may increase insulin sensitivity and glycemic control in diabetic
      patients, and may prevent the development of cardiovascular disease in diabetic patients.
      Given the enormous public health cost of diabetes, the prospect of being able to use a
      relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in
      achieving normal blood glucose level merits further study.

      We will examine the effects of placebo and chromium niacinate supplementation on the fasting
      glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic
      patients. We will determine these above parameters at baseline and after the 1, 2 and 3
      months of supplementation in diabetic patients. The long-term objective is to explore the
      efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the
      development of cardiovascular disease (CVD), and improve the life expectancy in diabetic
      population.

      Chromium supplements are widely used by the public and are available in many stores, such as
      Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace
      metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an
      essential vitamin for our body. This study plans to use chromium niacinate, a complex of
      chromium and niacin. Chromium niacinate is considered a nutrient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Blood Glucose Level
time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
description: Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.
measure: Blood Glucose Levels
time frame: Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.
description: Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.
measure: Lipid Levels
time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
description: Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.
measure: Blood Levels of Cytokines/Inflammatory Biomarkers
time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
description: Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group.
measure: Blood Levels of Cytokines/Inflammatory Biomarkers
time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
description: Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group.
measure: Blood Levels of Cytokines/Inflammatory Biomarkers
time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
description: Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group.
measure: Blood Levels of Cytokines/Inflammatory Biomarkers
time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
description: Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group.
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period.
arm group label: chromium niacinate
arm group type: Experimental
description: Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period
intervention type: Drug
intervention name: chromium niacinate
description: 200ug or 500ug supplementation in pill form
arm group label: chromium niacinate
intervention type: Drug
intervention name: placebo
description: Placebo pill for chromium niacinate
arm group label: placebo
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: No
last name: Sushil K Jain, Ph.D.
role: Principal Investigator
affiliation: Louisiana State University Health Sciences Center in Shreveport
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Chromium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 