Mechanisms of Prediabetic States in Sleep Apnea

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

Detailed Description
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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.

Official Title
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Mechanisms of Prediabetic States in Sleep Apnea

Conditions
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Sleep Apnea, Pre-diabetes

Intervention / Treatment
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* Device: Continuous positive airway pressure
* Other: Niacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Untreated<br>Untreated condition (obstructive sleep apnea) | |
| Active Comparator: Continuous positive airway pressure (CPAP) treatment<br>Continuous positive airway pressure (CPAP) treatment | Device: Continuous positive airway pressure<br>* Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)<br>* Other names: CPAP;|
| Active Comparator: Niacin<br>Untreated, pharmacological suppression of lipolysis by Niacin | Other: Niacin<br>* Suppression of lipolysis by niacin infusion<br>* Other names: Suppression of lipolysis by niacin infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep