Clinical trial NCT03307330: A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
Official title: A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea of Adult
Keywords: Obstructive Sleep Apnea
Adipose Tissue
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue
timeFrame: Day 2
Secondary outcomes:
measure: Prevalence of phosphorylated p53 (pp53) in adipose tissue
timeFrame: Day 2
measure: 24- h mean arterial pressure
timeFrame: Day 2
measure: Vascular endothelial function
timeFrame: Day 2
measure: Insulin sensitivity
timeFrame: Day 2
measure: Body composition
timeFrame: Day 1
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: