Fat Disorder, Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICEPAP Therapy
Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use
BEHAVIORALLifestyle Counseling Intervention
Lifestyle 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
Sponsors
University of Miami
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Aim 1 Group: Inclusion criteria: * Age between 18-70 years * Ability to provide consent
Exclusion criteria
* 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 * Use of oral corticosteroids * Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression) * Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h) * Use of supplemental oxygen during wakefulness or sleep * Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test * Resting awake Oxygen Saturation (SpO2) \< 90% Aim 2 Group: Inclusion criteria: * Age between 18-70 years * Ability to provide consent * Moderate-to-severe OSA (AHI ≥ 15/h); * Demonstration of Positive Airway Pressure (PAP) use of \> 4 h/night on 70% of the nights during 1-week run-in period * Successful completion of all of the procedures for Aim 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole body lipolysis rate | Up to 3 months | Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Free Fatty Acids (FFA) Oxidation Rate | Up to 3 months | Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months |
| Adipocyte insulin resistance | Up to 3 months | Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months |
| Lipolysis suppression slope | Up to 3 months | Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months |
| Free fatty acid rebound slope | Up to 3 months | Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months |
| Free fatty acid insulin sensitivity parameter | Up to 3 months | Measured using the IVGTT in (picomoles/L x min)\^-1 assessed at baseline and again at 3 months |
| Insulin sensitivity | Up to 3 months | Measured using the IVGTT in (milliunits/L x min)\^-1 assessed at baseline and again at 3 months |
| Acute insulin response to glucose | Up to 3 months | Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months |
| Glucose effectiveness | Up to 3 months | Measured using the IVGTT in per minute assessed at baseline and again at 3 months |
Countries
United States
Contacts
CONTACTNaresh Punjabi, MD
PRINCIPAL_INVESTIGATORNaresh Punjabi, MD
University of Miami
Outcome results
None listed