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NCT04234217 Clinical Trial

Mechanisms of Prediabetic States in Sleep Apnea

Sleep Apnea Clinical Trial

Official title:
Mechanisms of Prediabetic States in Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04234217
Other study ID # IRB19-0593
Secondary ID R01HL146127
Status Recruiting
Phase N/A
First received
Last updated
Start date November 26, 2019
Est. completion date December 31, 2025

Study information
Verified date May 2024
Source University of Chicago
Contact Becky Tucker, BA
Phone 773-702-2348
Email sleepstudy@uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Continuous positive airway pressure
Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)
Other:
• Niacin
Suppression of lipolysis by niacin infusion

Locations
Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (4)
Lead Sponsor Collaborator
University of Chicago AdventHealth, Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma norepinephrine levels Plasma norepinephrine will be measured in blood Untreated, within 4 months of screening
Primary Plasma norepinephrine levels Plasma norepinephrine will be measured in blood CPAP, within 4 months of screening
Primary Plasma norepinephrine levels Plasma norepinephrine will be measured in blood Niacin, within 4 months of screening
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