An interventional study of Pioglitazone and placebo in Insulin Sensitivity and Obstructive Sleep Apnea, sponsored by Stanford University. Completed. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-21.
Sponsored by Stanford University · Not applicable, Interventional, and Other
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
pioglitazone 45 mg, oral, daily
Drug: Pioglitazone
Placebo, one pill daily
Drug: placebo
45 mg daily Insulin sensitizing
Also known as: actos
Compare with pioglitazone
Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo
To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.
Time frame: 8 weeks
Recruitment Dates: July 10 2010 - March 2014
| Milestone | Pioglitazone | Placebo |
|---|---|---|
| Started | 30 | 15 |
| Completed | 30 | 15 |
| Not completed | 0 | 0 |
To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.
| AHI events/hour | Pioglitazone | Placebo |
|---|---|---|
| Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo | 35.8 (21 to 49) | 34.4 (18 to 47) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pioglitazone | — | 0/30 (0%) | 2/30 (6.7%) |
| Placebo | — | 0/15 (0%) | 0/15 (0%) |
| Event | Pioglitazone | Placebo |
|---|---|---|
| weight gainProduct Issues | 2/30 | 0/15 |
| Age, Continuous(years) | Pioglitazone | Placebo | Total |
|---|---|---|---|
| Mean | 51 ± 11 | 50 ± 12 | 50.5 ± 11.5 |
| Sex: Female, Male(Participants) | Pioglitazone | Placebo | Total |
|---|---|---|---|
| Female | 10 | 5 | 15 |
| Male | 20 | 10 | 30 |
| Changes in sleep measure(Apnea-hypopnea index (AHI) events/hour) | Pioglitazone | Placebo | Total |
|---|---|---|---|
| Mean | 36.9 ± 11.9 | 40.8 ± 12.3 | 38.9 ± 12.1 |
| Insulin Sensitivity(mmol/L) | Pioglitazone | Placebo | Total |
|---|---|---|---|
| Mean | 11.9 ± 2.1 | 12.3 ± 2.0 | 12.1 ± 2.1 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Stanford University