Mechanisms of Prediabetic States in Sleep Apnea

NCT04234217 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: IRB19-0593R01HL146127
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea; Pre-diabetes

Keywords

Sleep

Outcome Measures

Primary Outcomes (3)

• Plasma norepinephrine levels

  Plasma norepinephrine will be measured in blood

  Untreated, within 4 months of screening

• Plasma norepinephrine levels

  Plasma norepinephrine will be measured in blood

  CPAP, within 4 months of screening

• Plasma norepinephrine levels

  Plasma norepinephrine will be measured in blood

  Niacin, within 4 months of screening

Study Arms (3)

Untreated

NO INTERVENTION

Untreated condition (obstructive sleep apnea)

Continuous positive airway pressure (CPAP) treatment

ACTIVE COMPARATOR

Continuous positive airway pressure (CPAP) treatment

Device: Continuous positive airway pressure

Niacin

ACTIVE COMPARATOR

Untreated, pharmacological suppression of lipolysis by Niacin

Other: Niacin

Interventions

Niacin OTHER

Suppression of lipolysis by niacin infusion

Also known as: Suppression of lipolysis by niacin infusion

Niacin

Continuous positive airway pressure DEVICE

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

Also known as: CPAP

Continuous positive airway pressure (CPAP) treatment

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight or obese
• Prediabetic
• Sleep apnea

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Mayo Clinic: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• AdventHealth: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Glucose Intolerance

Interventions

Continuous Positive Airway Pressure; Niacin

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Esra Tasali, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 21, 2020
• Study Start: November 26, 2019
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)