Metabolism and Sleep Apnea Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami
About this trial
The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18-70 years
Ability to provide consent
Disqualifiers
Body Mass Index (BMI) > 40 kg/m2
Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
Type 1 or Type 2 diabetes mellitus
Current or prior use of PAP or oral appliance therapy for OSA
Trial design
Design model
Parallel
Treatments tested in this trial
PAP Therapy
DeviceAuto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use
Lifestyle Counseling Intervention
BehavioralLifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: No Intervention (Aim 1) GroupNo intervention 0 interventions
Group B: PAP Therapy and Lifestyle Intervention (Aim 2) GroupExperimental treatment 2 interventions
Group C: Lifestyle Intervention Only (Aim 2) GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Whole body lipolysis rate
Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months
Time frame
Up to 3 monthsSecondary outcomes
1
Free Fatty Acids (FFA) Oxidation Rate
Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months
Time frame
Up to 3 months2
Adipocyte insulin resistance
Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months
Time frame
Up to 3 months3
Lipolysis suppression slope
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months
Time frame
Up to 3 months4
Free fatty acid rebound slope
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months
Time frame
Up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov