Mechanisms of Prediabetic States in Sleep Apnea
Primary Purpose
Sleep Apnea, Pre-diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure
Niacin
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea focused on measuring Sleep
Eligibility Criteria
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
Sites / Locations
- University of ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Untreated
Continuous positive airway pressure (CPAP) treatment
Niacin
Arm Description
Untreated condition (obstructive sleep apnea)
Continuous positive airway pressure (CPAP) treatment
Untreated, pharmacological suppression of lipolysis by Niacin
Outcomes
Primary Outcome Measures
Plasma norepinephrine levels
Plasma norepinephrine will be measured in blood
Plasma norepinephrine levels
Plasma norepinephrine will be measured in blood
Plasma norepinephrine levels
Plasma norepinephrine will be measured in blood
Secondary Outcome Measures
Full Information
NCT ID
NCT04234217
First Posted
December 18, 2019
Last Updated
March 16, 2023
Sponsor
University of Chicago
Collaborators
Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), AdventHealth
1. Study Identification
Unique Protocol Identification Number
NCT04234217
Brief Title
Mechanisms of Prediabetic States in Sleep Apnea
Official Title
Mechanisms of Prediabetic States in Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
July 15, 2025 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), AdventHealth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Pre-diabetes
Keywords
Sleep
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Untreated
Arm Type
No Intervention
Arm Description
Untreated condition (obstructive sleep apnea)
Arm Title
Continuous positive airway pressure (CPAP) treatment
Arm Type
Active Comparator
Arm Description
Continuous positive airway pressure (CPAP) treatment
Arm Title
Niacin
Arm Type
Active Comparator
Arm Description
Untreated, pharmacological suppression of lipolysis by Niacin
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Other Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)
Intervention Type
Other
Intervention Name(s)
Niacin
Other Intervention Name(s)
Suppression of lipolysis by niacin infusion
Intervention Description
Suppression of lipolysis by niacin infusion
Primary Outcome Measure Information:
Title
Plasma norepinephrine levels
Description
Plasma norepinephrine will be measured in blood
Time Frame
Untreated, within 4 months of screening
Title
Plasma norepinephrine levels
Description
Plasma norepinephrine will be measured in blood
Time Frame
CPAP, within 4 months of screening
Title
Plasma norepinephrine levels
Description
Plasma norepinephrine will be measured in blood
Time Frame
Niacin, within 4 months of screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Becky Tucker, BA
Phone
773-702-2348
Email
sleepstudy@uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Tasali, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Tasali, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Mechanisms of Prediabetic States in Sleep Apnea
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