Obesity, Sleep Apnea, and Insulin Resistance

NCT02192684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-04-21

Study results available
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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.

Conditions

Interventions

DRUG

Pioglitazone

45 mg daily Insulin sensitizing

DRUG

placebo

Compare with pioglitazone

Sponsors & Collaborators

Principal Investigators

  • Gerald M Reaven, M.D. · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-07-31
Completion
2015-03-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02192684 on ClinicalTrials.gov