Mechanisms of Prediabetic States in Sleep Apnea

NCT ID: NCT04234217

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-26

Study Completion Date

2026-07-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Sleep Apnea Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Untreated

Untreated condition (obstructive sleep apnea)

Group Type NO_INTERVENTION

No interventions assigned to this group

Continuous positive airway pressure (CPAP) treatment

Continuous positive airway pressure (CPAP) treatment

Group Type ACTIVE_COMPARATOR

Continuous positive airway pressure

Intervention Type DEVICE

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

Niacin

Untreated, pharmacological suppression of lipolysis by Niacin

Group Type ACTIVE_COMPARATOR

Niacin

Intervention Type OTHER

Suppression of lipolysis by niacin infusion

Interventions

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Continuous positive airway pressure

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

Intervention Type DEVICE

Niacin

Suppression of lipolysis by niacin infusion

Intervention Type OTHER

Other Intervention Names

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CPAP Suppression of lipolysis by niacin infusion

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

AdventHealth

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esra Tasali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Becky Tucker, BA

Role: CONTACT

773-702-2348

Other Identifiers

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R01HL146127

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB19-0593

Identifier Type: -

Identifier Source: org_study_id

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