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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea of Adult

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstructive Sleep Apnea<br>Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) >=5 | |
| Non-Obstructive Sleep Apnea<br>Non-Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) < 5 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Adipose Tissue