Insulin Sensitivity, Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, insulin sensitivity, cardiovascular risk, positive airway pressure therapy
Brief 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.
Interventions
DRUGPioglitazone
45 mg daily Insulin sensitizing
DRUGplacebo
Compare with pioglitazone
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo | 8 weeks | To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA. |
Participant flow
Recruitment details
Recruitment Dates: July 10 2010 - March 2014
Participants by arm
| Arm | Count |
|---|---|
| Pioglitazone pioglitazone 45 mg, oral, daily
Pioglitazone: 45 mg daily Insulin sensitizing | 30 |
| Placebo Placebo, one pill daily
placebo: Compare with pioglitazone | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | Placebo | Total | Pioglitazone |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 12 | 50.5 years STANDARD_DEVIATION 11.5 | 51 years STANDARD_DEVIATION 11 |
| Changes in sleep measure | 40.8 Apnea-hypopnea index (AHI) events/hour STANDARD_DEVIATION 12.3 | 38.9 Apnea-hypopnea index (AHI) events/hour STANDARD_DEVIATION 12.1 | 36.9 Apnea-hypopnea index (AHI) events/hour STANDARD_DEVIATION 11.9 |
| Insulin Sensitivity | 12.3 mmol/L STANDARD_DEVIATION 2 | 12.1 mmol/L STANDARD_DEVIATION 2.1 | 11.9 mmol/L STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 30 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 30 | 0 / 15 |
| serious Total, serious adverse events | 0 / 30 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pioglitazone | Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo | 35.8 AHI events/hour |
| Placebo | Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo | 34.4 AHI events/hour |