Clincosm LogoSign in Get a demo

Mechanisms of Prediabetic States in Sleep Apnea

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04234217
Collaborator
Mayo Clinic (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH), AdventHealth (Other)
300
Enrollment
1
Location
3
Arms
67.6
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous positive airway pressure
  • Other: Niacin
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Mechanisms of Prediabetic States in Sleep Apnea
Actual Study Start Date :
Nov 26, 2019
Anticipated Primary Completion Date :
Jul 15, 2025
Anticipated Study Completion Date :
Jul 15, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Untreated

Untreated condition (obstructive sleep apnea)
Active Comparator: Continuous positive airway pressure (CPAP) treatment

Continuous positive airway pressure (CPAP) treatment

Device: Continuous positive airway pressure
Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)
Other Names:
  • CPAP

    		•
    Active Comparator: Niacin

    Untreated, pharmacological suppression of lipolysis by Niacin

    Other: Niacin
    Suppression of lipolysis by niacin infusion
    Other Names:
  • Suppression of lipolysis by niacin infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma norepinephrine levels [Untreated, within 4 months of screening]

      Plasma norepinephrine will be measured in blood

    2. Plasma norepinephrine levels [CPAP, within 4 months of screening]

      Plasma norepinephrine will be measured in blood

    3. Plasma norepinephrine levels [Niacin, within 4 months of screening]

      Plasma norepinephrine will be measured in blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Esra Tasali, MD, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT04234217
    Other Study ID Numbers:
    • IRB19-0593
    • R01HL146127
    First Posted:
    Jan 21, 2020
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by University of Chicago
    Sleep
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Prediabetic State
    Niacin
    Niacinamide
    Nicotinic Acids

    Study Results

    No Results Posted as of Apr 21, 2022