A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
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.
Conditions:
🦠 Obstructive Sleep Apnea of Adult
🗓️ Study Start (Actual) 8 January 2018
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 120
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

  • 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: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 October 2017
  • First Submitted that Met QC Criteria 6 October 2017
  • First Posted 11 October 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 March 2024
  • Last Update Posted 20 March 2024
  • Last Verified March 2024