Mechanisms of Prediabetic States in Sleep Apnea

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04234217

Enrollment

300

Registered

2020-01-21

Start date

2019-11-26

Completion date

2026-07-15

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes, Sleep Apnea

Keywords

Sleep

Brief summary

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

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.

Interventions

DEVICEContinuous positive airway pressure

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

OTHERNiacin

Suppression of lipolysis by niacin infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma norepinephrine levels	Untreated, within 4 months of screening	Plasma norepinephrine will be measured in blood

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREsra Tasali, MD

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026