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A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03307330
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : March 15, 2023
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Virend Somers, MD, PhD, Mayo Clinic

Brief Summary:
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.

Condition or disease
Obstructive Sleep Apnea of Adult

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : July 2026

Obstructive Sleep Apnea
Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) >=5
Non-Obstructive Sleep Apnea
Non-Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) < 5

Primary Outcome Measures :
  1. Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue [ Time Frame: Day 2 ]
    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.

Secondary Outcome Measures :
  1. Prevalence of phosphorylated p53 (pp53) in adipose tissue [ Time Frame: Day 2 ]
    Presence of pp53 as a ratio of phospho to total p53 to access cellular damage in adipose tissue.

  2. 24- h mean arterial pressure [ Time Frame: Day 2 ]
    ambulatory measure of blood pressure in mmHg

  3. Vascular endothelial function [ Time Frame: Day 2 ]
    Change in Brachial artery diameter in response to hyperemia

  4. Insulin sensitivity [ Time Frame: Day 2 ]
    Oral glucose tolerance testing

  5. Body composition [ Time Frame: Day 1 ]
    Percentage body fat content

Biospecimen Retention:   Samples With DNA
Blood samples Fat tissue Urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with obstructive sleep apnea and healthy subjects without chronic diseases and interested in participating will be enrolled in this study.

Inclusion Criteria

  • BMI ≤40 kg/m2
  • Not a current smoker or tobacco user
  • Individuals with treated hypertension, prehypertension, and dyslipidemia will be allowed to participate in the study
  • On no prescription medications other than those medications used to treat asthma, seasonal or environmental allergies (such as Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), depression, acid reflux (such as antacids or proton pump inhibitors), topical skin treatment medications or shampoos, contraceptive pills, or intrauterine devices. Other medications may be allowed at the discretion of the study staff.
  • Not pregnant or breast feeding and not intending to become pregnant or breast feed
  • Ability to provide written informed consent
  • If a subject is on aspirin or any other anti-inflammatory medication but free of known vascular disease and depending on the indication, the study doctor may ask the subject to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the study. In the event that the subject does not stop the aspirin or other anti-inflammatory medication, they will not be able to participate in the study because of the risk of bleeding during the fat biopsy.

Exclusion Criteria

  • Vulnerable study population will be excluded
  • Presence of chronic kidney disease (creatinine >2.5 mg/dL) and/or active cancers
  • Pregnancy
  • Anemic (hemoglobin <12 g/dL for men and <11 g/dL for women)
  • Smoking
  • Use of chronic medications (statins, anti-inflammatory drugs, angiotensin II receptor blockers (ARBs) and/or angiotensin-converting enzyme (ACE) inhibitors)
  • Blood or plasma donation during the past 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307330

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Contact: Somers_CPL Lab 507-255-8794 CPLOSA@mayo.edu
Contact: Virend Somers, MD., Ph.D 507-255-1144 somers.virend@mayo.edu

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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Somers_CPL LAB    507-255-8794    CPLOSA@mayo.edu   
Contact: Virend Somers, MD, Ph.D    507-255-1144    somers.virend@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Virend Somers, MD., Ph.D Mayo Clinic
Additional Information:
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Responsible Party: Virend Somers, MD, PhD, Consultant, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03307330    
Other Study ID Numbers: 17-003825
R01HL065176 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virend Somers, MD, PhD, Mayo Clinic:
Obstructive Sleep Apnea
Adipose Tissue
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases