Obesity, Sleep Apnea, and Insulin Resistance

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.

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Key information

Conditions

Insulin Sensitivity Apnea Dyssomnias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pioglitazone

Drug

45 mg daily Insulin sensitizing

Other names: actos

Placebo

Drug

Compare with pioglitazone

Primary outcomes

Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo

Time frame: 8 weeks

To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Interfacing Adiposity, Sleep Apnea, and Insulin Resistance

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2015
First posted: Jul 17, 2014
Registry last updated: Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed