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

Mayo Clinic

Status

Enrolling

Conditions

Obstructive Sleep Apnea of Adult

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT03307330

17-003825

R01HL065176 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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