NCT03307330

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
44mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2018Dec 2029

First Submitted

Initial submission to the registry

October 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

11.9 years

First QC Date

October 6, 2017

Last Update Submit

February 11, 2026

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Obstructive Sleep ApneaAdipose Tissue

Outcome Measures

Primary Outcomes (1)

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

    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.

    Day 2

Secondary Outcomes (5)

  • Prevalence of phosphorylated p53 (pp53) in adipose tissue

    Day 2

  • 24- h mean arterial pressure

    Day 2

  • Vascular endothelial function

    Day 2

  • Insulin sensitivity

    Day 2

  • Body composition

    Day 1

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Fat tissue Urine

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Virend Somers, MD., Ph.D

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Somers_CPL Lab

CONTACT

507-255-8794CPLOSA@mayo.edu

Virend Somers, MD., Ph.D

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Professor of Medicine

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 11, 2017

Study Start

January 8, 2018

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(1)