Metabolism and Sleep Apnea Treatment (MaST)

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Fat Disorder
• Intervention / Treatment: Device: PAP Therapy; Behavioral: Lifestyle Counseling Intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naresh Punjabi, MD; Phone Number: 305-243-3963; Email: npunjabi@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Recruiting
      • University of Miami
      • Contact: Naresh Punjabi, MD; Phone Number: 305-243-3963; Email: npunjabi@miami.edu
      • Principal Investigator: Naresh Punjabi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion criteria:

• BMI: ≥ 40 kg/m2
• Type 1 or Type 2 diabetes mellitus
• Current use of PAP or oral appliance therapy for OSA
• Commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
• Epworth sleepiness score of 18 or more
• Use of oral corticosteroids
• Participation in another clinical trial
• 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 SpO2 < 90%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention (Aim 1) Group; Participants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity.
Experimental: PAP Therapy and Lifestyle Intervention (Aim 2) Group; Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks.	Device: PAP 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; Behavioral: Lifestyle 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
Experimental: Lifestyle Intervention Only (Aim 2) Group; Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks.	Behavioral: Lifestyle 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole body lipolysis rate	Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free Fatty Acids (FFA) Oxidation Rate	Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months	Up to 3 months
Adipocyte insulin resistance	Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months	Up to 3 months
Lipolysis suppression slope	Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months	Up to 3 months
Free fatty acid rebound slope	Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months	Up to 3 months
Free fatty acid insulin sensitivity parameter	Measured using the IVGTT in (picomoles/L x min)^-1 assessed at baseline and again at 3 months	Up to 3 months
Insulin sensitivity	Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months	Up to 3 months
Acute insulin response to glucose	Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months	Up to 3 months
Glucose effectiveness	Measured using the IVGTT in per minute assessed at baseline and again at 3 months	Up to 3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Naresh Punjabi, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 20210670; 5R01HL146709-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No