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Obesity, Sleep Apnea, and Insulin Resistance

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Stanford University

Status

Completed

Conditions

Obstructive Sleep Apnea
Insulin Sensitivity

Treatments

Drug: placebo
Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT02192684
5U01HL108647-04

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 2 patient groups, including a placebo group

pioglitazone
Active Comparator group
Description:
pioglitazone 45 mg, oral, daily
Treatment:
Drug: Pioglitazone
placebo
Placebo Comparator group
Description:
Placebo, one pill daily
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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