Observational Study of Adipose Tissue in Obstructive Sleep Apnea

This study is looking at how obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep, affects fat tissue. We know that OSA can increase the risk of heart problems and is linked to obesity, and fat tissue itself plays a role in heart disease. The goal is to understand how OSA changes the cells in fat tissue. Researchers will compare fat tissue from people with OSA to fat tissue from healthy individuals to see if there are more damaged cells in those with OSA. This study is for adults aged 18 to 60 with a BMI of 40 or less, who are not current smokers. The study is currently unclear on its recruitment status.

Study design
This is an observational study planning to include 120 participants. It is not testing a specific intervention or drug.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, looking at specific cell markers in fat tissue, is measured at Day 2. No further follow-up is specified.

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NCT03307330

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

Recruiting
Not specifiedAges 18–60Observational
Mayo Clinic
~120 participants
Updated 2026-02-13 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue
Measured over Day 2
Obstructive Sleep Apnea of Adult
1 sites across 1 states
Minnesota1
  • Virend Somers, MD., Ph.D · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissueDay 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.