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

Recruiting

• Conditions: Obstructive Sleep Apnea of Adult

• Registration Number: NCT03307330
• Lead Sponsor: Mayo Clinic

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-11
• Study Start: 2018-01-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue	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 Outcome Measures

Name	Time	Method
24- h mean arterial pressure	Day 2	ambulatory measure of blood pressure in mmHg
Vascular endothelial function	Day 2	Change in Brachial artery diameter in response to hyperemia
Insulin sensitivity	Day 2	Oral glucose tolerance testing
Prevalence of phosphorylated p53 (pp53) in adipose tissue	Day 2	Presence of pp53 as a ratio of phospho to total p53 to access cellular damage in adipose tissue.
Body composition	Day 1	Percentage body fat content

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States