Mechanisms of Prediabetic States in Sleep Apnea

April 23, 2026 updated by: University of Chicago
The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Untreated
Untreated condition (obstructive sleep apnea)
Active Comparator: Continuous positive airway pressure (CPAP) treatment
Device: Continuous positive airway pressure
Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)
Other Names:
  • CPAP
Active Comparator: Niacin
Untreated, pharmacological suppression of lipolysis by Niacin
Other: Niacin
Suppression of lipolysis by niacin infusion
Other Names:
  • Suppression of lipolysis by niacin infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma norepinephrine levels
Time Frame: Untreated, within 4 months of screening
Plasma norepinephrine will be measured in blood
Untreated, within 4 months of screening
Plasma norepinephrine levels
Time Frame: CPAP, within 4 months of screening
Plasma norepinephrine will be measured in blood
CPAP, within 4 months of screening
Plasma norepinephrine levels
Time Frame: Niacin, within 4 months of screening
Plasma norepinephrine will be measured in blood
Niacin, within 4 months of screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

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

Investigators

  • Principal Investigator: Esra Tasali, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2019

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB19-0593
  • R01HL146127 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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