Health TrialsbyHealthPanel

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

ConditionObstructive Sleep Apnea of Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

Subjects with obstructive sleep apnea and healthy subjects without chronic diseases and interested in participating will be enrolled in this study.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Obstructive Sleep Apnea
Group B: Non-Obstructive Sleep Apnea

Trial outcomes

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.

Time frame
Day 2

Secondary outcomes

1

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.

Time frame
Day 2
2

24- h mean arterial pressure

ambulatory measure of blood pressure in mmHg

Time frame
Day 2
3

Vascular endothelial function

Change in Brachial artery diameter in response to hyperemia

Time frame
Day 2
4

Insulin sensitivity

Oral glucose tolerance testing

Time frame
Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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