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NCT Number: NCT03307330

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Somers_CPL Lab

CONTACT

[email protected]

507-255-8794

Virend Somers, MD., Ph.D

CONTACT

[email protected]

507-255-1144

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2018
Primary completion
2029
Study completion
2029
First posted
Oct 11, 2017
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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