Examining fat tissue in people with obstructive sleep apnea
A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
This study looks at how obstructive sleep apnea affects fat tissue in people and whether these changes could increase the risk of heart and metabolic problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03307330 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how obstructive sleep apnea (OSA) affects the cellular and molecular composition of adipose tissue compared to healthy individuals. Researchers will analyze adipose tissue samples to identify markers of cellular damage and understand the implications for cardiovascular disease risk. The study seeks to fill the knowledge gap regarding OSA-induced changes in fat tissue and their potential role in developing cardiometabolic disorders. By examining these changes, the study hopes to uncover pathways that could be targeted for therapeutic interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a body mass index (BMI) of 40 kg/m2 or less who do not smoke and have controlled hypertension or dyslipidemia.
Not a fit: Patients who are pregnant, breastfeeding, or have a BMI over 40 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for reducing cardiovascular disease risk in patients with obstructive sleep apnea.
How similar studies have performed: While there is ongoing research into the relationship between adipose tissue and cardiovascular disease, this specific examination of adipose tissue changes in obstructive sleep apnea is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Virend Somers, MD., Ph.D — Mayo Clinic
- Study coordinator: Somers_CPL Lab
- Email: CPLOSA@mayo.edu
- Phone: 507-255-8794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.