Mechanisms of Prediabetic States in Sleep Apnea

Not Applicable

Recruiting

• Conditions: Sleep Apnea; Pre-diabetes
• Interventions: Other: Niacin; Device: Continuous positive airway pressure

• Registration Number: NCT04234217
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 2019-11-26
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Niacin	Niacin	Untreated, pharmacological suppression of lipolysis by Niacin
Continuous positive airway pressure (CPAP) treatment	Continuous positive airway pressure	Continuous positive airway pressure (CPAP) treatment

Primary Outcome Measures

Name	Time	Method
Plasma norepinephrine levels	Niacin, within 4 months of screening	Plasma norepinephrine will be measured in blood

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States