Status:
RECRUITING
A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Sleep Apnea of Adult
Eligibility:
All Genders
18-60 years
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...
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 damag...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03307330
Start Date
January 8 2018
End Date
December 1 2029
Last Update
January 7 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55901