Metabolism and Sleep Apnea Treatment

Not Applicable

Recruiting

• Conditions: Fat Disorder; Obstructive Sleep Apnea
• Interventions: Device: PAP Therapy; Behavioral: Lifestyle Counseling Intervention

• Registration Number: NCT05539716
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-16
• Study Start: 2022-05-20
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-06-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAP Therapy and Lifestyle Intervention (Aim 2) Group	PAP Therapy	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.
PAP Therapy and Lifestyle Intervention (Aim 2) Group	Lifestyle Counseling Intervention	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.
Lifestyle Intervention Only (Aim 2) Group	Lifestyle Counseling Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
Glucose effectiveness	Up to 3 months	Measured using the IVGTT in per minute 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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States