<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/NCT03307330</url>
  </required_header>
  <id_info>
    <org_study_id>17-003825</org_study_id>
    <secondary_id>R01HL065176</secondary_id>
    <nct_id>NCT03307330</nct_id>
  </id_info>
  <brief_title>A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea</brief_title>
  <official_title>A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      Studies show that sleep apnea increases the risk of cardiovascular disease and is associated&#xD;
      with obesity. However, it is unclear how sleep apnea affects fat tissue. Studies have shown&#xD;
      that fat tissue is likely involved in developing cardiovascular disease. The purpose of this&#xD;
      study is to see how sleep apnea changes fat tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, the contribution of adipose tissue to obesity-related insulin resistance&#xD;
      (IR), diabetes mellitus and cardiovascular disease (CVD) has become clear.In particular,&#xD;
      accumulation of damaged cells in obese and aging adipose tissue has been shown to impair&#xD;
      adipose tissue function and may thus increase CVD risk. Cellular and molecular alterations in&#xD;
      adipose tissue are known to contribute to adipose tissue and systemic insulin resistance,&#xD;
      chronic inflammation, and may lead to higher blood pressure. Importantly, any clinical&#xD;
      consequences of adipose tissue dysfunction would be compounded by the large amount, and&#xD;
      central metabolic role, of adipose tissue in humans. However, there is a gap in our&#xD;
      understanding of the OSA-induced changes in the adipose tissue and its implication for&#xD;
      development of cardiometabolic disorders.&#xD;
&#xD;
      The aim of this study is to examine the cellular and molecular composition of adipose tissue&#xD;
      in obstructive sleep apnea (OSA) subjects in comparison to adipose tissue from healthy&#xD;
      individuals. We hypothesize that adipose tissue from OSA subjects will have a higher&#xD;
      accumulation of markers of cellular damage with positive p16 and γH2AX. These studies will&#xD;
      provide pivotal insights into pathways that may be targeted to reduce cardiometabolic burden&#xD;
      in OSA population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue</measure>
    <time_frame>Day 2</time_frame>
    <description>Positivity for both (p16^IND4A and γH2AX) serves as a marker of cellular damage. A fat biopsy from the abdomen and thigh will be performed to obtain up to 1 gm of adipose tissue from each site. These fat samples will be batched for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of phosphorylated p53 (pp53) in adipose tissue</measure>
    <time_frame>Day 2</time_frame>
    <description>Presence of pp53 as a ratio of phospho to total p53 to access cellular damage in adipose tissue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24- h mean arterial pressure</measure>
    <time_frame>Day 2</time_frame>
    <description>ambulatory measure of blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular endothelial function</measure>
    <time_frame>Day 2</time_frame>
    <description>Change in Brachial artery diameter in response to hyperemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>Day 2</time_frame>
    <description>Oral glucose tolerance testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage body fat content</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Obstructive Sleep Apnea of Adult</condition>
  <arm_group>
    <arm_group_label>Obstructive Sleep Apnea</arm_group_label>
    <description>Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) &gt;=5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Obstructive Sleep Apnea</arm_group_label>
    <description>Non-Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) &lt; 5</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples Fat tissue Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with obstructive sleep apnea and healthy subjects without chronic diseases and&#xD;
        interested in participating will be enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  BMI ≤40 kg/m2&#xD;
&#xD;
          -  Not a current smoker or tobacco user&#xD;
&#xD;
          -  Individuals with treated hypertension, prehypertension, and dyslipidemia will be&#xD;
             allowed to participate in the study&#xD;
&#xD;
          -  On no prescription medications other than those medications used to treat asthma,&#xD;
             seasonal or environmental allergies (such as Cetirizine, Fexofenadine, Desloratadine,&#xD;
             Loratadine, etc), depression, acid reflux (such as antacids or proton pump&#xD;
             inhibitors), topical skin treatment medications or shampoos, contraceptive pills, or&#xD;
             intrauterine devices. Other medications may be allowed at the discretion of the study&#xD;
             staff.&#xD;
&#xD;
          -  Not pregnant or breast feeding and not intending to become pregnant or breast feed&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
          -  If a subject is on aspirin or any other anti-inflammatory medication but free of known&#xD;
             vascular disease and depending on the indication, the study doctor may ask the subject&#xD;
             to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in&#xD;
             the study. In the event that the subject does not stop the aspirin or other&#xD;
             anti-inflammatory medication, they will not be able to participate in the study&#xD;
             because of the risk of bleeding during the fat biopsy.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Vulnerable study population will be excluded&#xD;
&#xD;
          -  Presence of chronic kidney disease (creatinine &gt;2.5 mg/dL) and/or active cancers&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Anemic (hemoglobin &lt;12 g/dL for men and &lt;11 g/dL for women)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Use of chronic medications (statins, anti-inflammatory drugs, angiotensin II receptor&#xD;
             blockers (ARBs) and/or angiotensin-converting enzyme (ACE) inhibitors)&#xD;
&#xD;
          -  Blood or plasma donation during the past 2 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virend Somers, MD., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Somers_CPL Lab</last_name>
    <phone>507-255-8794</phone>
    <email>CPLOSA@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Virend Somers, MD., Ph.D</last_name>
    <phone>507-255-1144</phone>
    <email>somers.virend@mayo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Somers_CPL LAB</last_name>
      <phone>507-255-8794</phone>
      <email>CPLOSA@mayo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Virend Somers, MD, Ph.D</last_name>
      <phone>507-255-1144</phone>
      <email>somers.virend@mayo.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Virend Somers, MD, PhD</investigator_full_name>
    <investigator_title>Consultant, Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Adipose Tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03307330
org study id: 17-003825
secondary id: R01HL065176
nct id: NCT03307330
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Studies show that sleep apnea increases the risk of cardiovascular disease and is associated
      with obesity. However, it is unclear how sleep apnea affects fat tissue. Studies have shown
      that fat tissue is likely involved in developing cardiovascular disease. The purpose of this
      study is to see how sleep apnea changes fat tissue.
In recent years, the contribution of adipose tissue to obesity-related insulin resistance
      (IR), diabetes mellitus and cardiovascular disease (CVD) has become clear.In particular,
      accumulation of damaged cells in obese and aging adipose tissue has been shown to impair
      adipose tissue function and may thus increase CVD risk. Cellular and molecular alterations in
      adipose tissue are known to contribute to adipose tissue and systemic insulin resistance,
      chronic inflammation, and may lead to higher blood pressure. Importantly, any clinical
      consequences of adipose tissue dysfunction would be compounded by the large amount, and
      central metabolic role, of adipose tissue in humans. However, there is a gap in our
      understanding of the OSA-induced changes in the adipose tissue and its implication for
      development of cardiometabolic disorders.

      The aim of this study is to examine the cellular and molecular composition of adipose tissue
      in obstructive sleep apnea (OSA) subjects in comparison to adipose tissue from healthy
      individuals. We hypothesize that adipose tissue from OSA subjects will have a higher
      accumulation of markers of cellular damage with positive p16 and γH2AX. These studies will
      provide pivotal insights into pathways that may be targeted to reduce cardiometabolic burden
      in OSA population.
observational model: Case-Control
time perspective: Prospective
measure: Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue
time frame: Day 2
description: Positivity for both (p16^IND4A and γH2AX) serves as a marker of cellular damage. A fat biopsy from the abdomen and thigh will be performed to obtain up to 1 gm of adipose tissue from each site. These fat samples will be batched for analysis.
measure: Prevalence of phosphorylated p53 (pp53) in adipose tissue
time frame: Day 2
description: Presence of pp53 as a ratio of phospho to total p53 to access cellular damage in adipose tissue.
measure: 24- h mean arterial pressure
time frame: Day 2
description: ambulatory measure of blood pressure in mmHg
measure: Vascular endothelial function
time frame: Day 2
description: Change in Brachial artery diameter in response to hyperemia
measure: Insulin sensitivity
time frame: Day 2
description: Oral glucose tolerance testing
measure: Body composition
time frame: Day 1
description: Percentage body fat content
arm group label: Obstructive Sleep Apnea
description: Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) >=5
arm group label: Non-Obstructive Sleep Apnea
description: Non-Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) < 5
Blood samples Fat tissue Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Virend Somers, MD., Ph.D
role: Principal Investigator
affiliation: Mayo Clinic
last name: Somers_CPL Lab
phone: 507-255-8794
email: CPLOSA@mayo.edu
last name: Virend Somers, MD., Ph.D
phone: 507-255-1144
email: somers.virend@mayo.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Virend Somers, MD, PhD
investigator title: Consultant, Professor of Medicine
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive