N/A
N=45
Obesity, Sleep Apnea, and Insulin Resistance
Insulin Sensitivity · Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02192684 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo — 35.8; 34.4 AHI events/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pioglitazone (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo |
35.8; 34.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02192684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.