Obesity, Sleep Apnea, and Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.

Official Title
-----------------
Interfacing Adiposity, Sleep Apnea, and Insulin Resistance

Conditions
-----------------
Insulin Sensitivity, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Drug: Pioglitazone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Individuals Age 30-70 years old BMI- 25-40 kg/m2 Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography Exclusion Criteria: Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer. Must not have previously received treatment for OSA, including CPAP. Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity. Pregnancy/lactation is also an exclusion.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pioglitazone<br>pioglitazone 45 mg, oral, daily | Drug: Pioglitazone<br>* 45 mg daily Insulin sensitizing<br>* Other names: actos;|
| Placebo Comparator: placebo<br>Placebo, one pill daily | Drug: placebo<br>* Compare with pioglitazone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo | To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, insulin sensitivity, cardiovascular risk, positive airway pressure therapy