Obesity, Sleep Apnea, and Insulin Resistance

Not Applicable

Completed

• Conditions: Insulin Sensitivity; Obstructive Sleep Apnea
• Interventions: Drug: placebo; Drug: Pioglitazone

• Registration Number: NCT02192684
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-17
• Study Completion: 2015-03
• Results First Submitted: 2016-11-18
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Placebo, one pill daily
pioglitazone	Pioglitazone	pioglitazone 45 mg, oral, daily

Primary Outcome Measures

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