Trial Outcomes & Findings for Obesity, Sleep Apnea, and Insulin Resistance (NCT NCT02192684)

Results Overview

To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-04-21

Recruitment Dates: July 10 2010 - March 2014

Participant milestones
Measure	Pioglitazone pioglitazone 45 mg, oral, daily Pioglitazone: 45 mg daily Insulin sensitizing	Placebo Placebo, one pill daily placebo: Compare with pioglitazone
Overall Study STARTED	30	15
Overall Study COMPLETED	30	15
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Obesity, Sleep Apnea, and Insulin Resistance

Baseline characteristics by cohort
Measure	Pioglitazone n=30 Participants pioglitazone 45 mg, oral, daily Pioglitazone: 45 mg daily Insulin sensitizing	Placebo n=15 Participants Placebo, one pill daily placebo: Compare with pioglitazone	Total n=45 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 11 • n=5 Participants	50 years STANDARD_DEVIATION 12 • n=7 Participants	50.5 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Changes in sleep measure	36.9 Apnea-hypopnea index (AHI) events/hour STANDARD_DEVIATION 11.9 • n=5 Participants	40.8 Apnea-hypopnea index (AHI) events/hour STANDARD_DEVIATION 12.3 • n=7 Participants	38.9 Apnea-hypopnea index (AHI) events/hour STANDARD_DEVIATION 12.1 • n=5 Participants
Insulin Sensitivity	11.9 mmol/L STANDARD_DEVIATION 2.1 • n=5 Participants	12.3 mmol/L STANDARD_DEVIATION 2.0 • n=7 Participants	12.1 mmol/L STANDARD_DEVIATION 2.1 • n=5 Participants

Timeframe: 8 weeks

To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.

Outcome measures
Measure	Pioglitazone n=30 Participants pioglitazone 45 mg, oral, daily Pioglitazone: 45 mg daily Insulin sensitizing	Placebo n=15 Participants Placebo, one pill daily placebo: Compare with pioglitazone
Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo	35.8 AHI events/hour Interval 21.0 to 49.0	34.4 AHI events/hour Interval 18.0 to 47.0

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Pioglitazone n=30 participants at risk pioglitazone 45 mg, oral, daily Pioglitazone: 45 mg daily Insulin sensitizing	Placebo n=15 participants at risk Placebo, one pill daily placebo: Compare with pioglitazone
Product Issues weight gain	6.7% 2/30 • Number of events 2	0.00% 0/15

Stanford Universtiy

Phone: 650-724-3416