Mechanisms of Prediabetic States in Sleep Apnea

The University of Chicago

Status: Enrolling

Conditions: Pre-diabetes; Sleep Apnea

Treatments: Other: Niacin; Device: Continuous positive airway pressure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04234217

R01HL146127 (U.S. NIH Grant/Contract)

IRB19-0593

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Untreated

No Intervention group

Description:

Untreated condition (obstructive sleep apnea)

Continuous positive airway pressure (CPAP) treatment

Active Comparator group

Description:

Continuous positive airway pressure (CPAP) treatment

Treatment:

Device: Continuous positive airway pressure

Niacin

Active Comparator group

Description:

Untreated, pharmacological suppression of lipolysis by Niacin

Treatment:

Other: Niacin