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NCT Number: NCT04234217

Mechanisms of Prediabetic States in Sleep Apnea

The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pre-diabetes Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Overweight or obese
  • Prediabetic
  • Sleep apnea

Exclusion criteria

  • Diabetic
  • Severe hypertension
  • Taking medications that can confound assessments
  • Any history of known bleeding disorders
  • Any underlying disease likely to limit life span or increase risk of intervention
  • Currently pregnant, trying to get pregnant or nursing

Treatment and study plan

Continuous Positive Airway Pressure

Device

Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)

Other names: CPAP

Niacin

Other

Suppression of lipolysis by niacin infusion

Other names: Suppression of lipolysis by niacin infusion

Primary outcomes

  1. Plasma norepinephrine levels

    Time frame: Untreated, within 4 months of screening

    Plasma norepinephrine will be measured in blood

  2. Plasma norepinephrine levels

    Time frame: CPAP, within 4 months of screening

    Plasma norepinephrine will be measured in blood

  3. Plasma norepinephrine levels

    Time frame: Niacin, within 4 months of screening

    Plasma norepinephrine will be measured in blood

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • AdventHealth
  • Mayo Clinic
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2020
Registry last updated
Apr 24, 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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