Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Study Overview
=================
Brief Summary
-----------------
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.

Detailed Description
-----------------
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.

Official Title
-----------------
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Conditions
-----------------
Diabetes, Sleep Apnea

Intervention / Treatment
-----------------
* Device: CPAP mask
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight or obese adults (age ≥45 yrs and BMI ≥25 kg/m2) prediabetes and OSA (AHI ≥ 5) regular life styles and schedules (no shift work in the past 6 months, no travel across time zones during the past 4 weeks) habitual bedtimes of at least 6 hours but not exceeding 9 hours will be eligible. not to take any medications during the study period with the exception of antihypertensives and lipid lowering agents not on hormone replacement therapy. have sedentary activities and no competitive athletes or subjects with high exercise levels. Exclusion Criteria: previous or current treatment with supplemental oxygen requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration presence of active infection, psychiatric disease or history of other significant illness (e.g., myocardial infarction, congestive heart failure, stroke, arrhythmia, chronic kidney or liver disease0 clinical depression as evidenced by a score >16 in CES-D scale smoking, or routine alcohol use (more than 2 drinks per day), or excessive caffeine intake (>300mg per day)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous positive airway pressure<br>2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night | Device: CPAP mask<br>* The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity. ________________________________________<br>* Other names: continuous positive airway pressure therapy;|
| Placebo Comparator: Placebo<br>2 weeks of oral administration of a placebo tablet 30min before bedtime | Drug: Placebo<br>* oral placebo tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2 | The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline. | Baseline and Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Insulin Sensitivity (SI) at Week 2 | SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT). Change = Week 2 - Baseline. | Baseline and Week 2 | 
| Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2 | The average systolic blood pressure measured over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline. | Baseline and Week 2 | 
| Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2 | The average diastolic blood pressure over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline | Baseline and Week 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPAP, diabetes, sleep apnea