Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT03307330

Conditions

Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Obstructive Sleep Apnea of Adult

Study ID

NCT03307330

Start date

Jan 8, 2018

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue [ Time Frame: Day 2 ]

Central Contacts and Locations

Central contacts

Somers_CPL Lab

507-255-8794CPLOSA@mayo.edu

Virend Somers, MD., Ph.D

507-255-1144somers.virend@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55901

Contacts

Somers_CPL LAB

507-255-8794CPLOSA@mayo.edu

Virend Somers, MD, Ph.D

507-255-1144somers.virend@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • Obstructive Sleep Apnea
  • Adipose Tissue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.