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NCT Number: NCT05539716

Metabolism and Sleep Apnea Treatment

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33143, United States

Location status: Recruiting

Location contact

Naresh Punjabi, MD

CONTACT

[email protected]

305-243-3963

Naresh Punjabi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

PAP Therapy

Device

Auto-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

Behavioral

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

Primary outcomes

  1. Whole body lipolysis rate

    Time frame: 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 outcomes

  1. Free Fatty Acids (FFA) Oxidation Rate

    Time frame: Up to 3 months

    Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months

  2. Adipocyte insulin resistance

    Time frame: Up to 3 months

    Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months

  3. Lipolysis suppression slope

    Time frame: Up to 3 months

    Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months

  4. Free fatty acid rebound slope

    Time frame: Up to 3 months

    Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months

  5. Free fatty acid insulin sensitivity parameter

    Time frame: Up to 3 months

    Measured using the IVGTT in (picomoles/L x min)^-1 assessed at baseline and again at 3 months

  6. Insulin sensitivity

    Time frame: Up to 3 months

    Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months

  7. Acute insulin response to glucose

    Time frame: Up to 3 months

    Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months

  8. Glucose effectiveness

    Time frame: Up to 3 months

    Measured using the IVGTT in per minute assessed at baseline and again at 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Naresh Punjabi, MD

CONTACT

[email protected]

305-243-3963

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: MaST

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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