Trial Outcomes & Findings for Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk (NCT NCT01156116)

Results Overview

The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Baseline and Week 2

Results posted on

2015-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Positive Airway Pressure 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	Placebo 2 weeks of oral administration of a placebo tablet 30min before bedtime
Overall Study STARTED	26	13
Overall Study COMPLETED	21	12
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous Positive Airway Pressure 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	Placebo 2 weeks of oral administration of a placebo tablet 30min before bedtime
Overall Study Withdrawal by Subject	3	1
Overall Study CPAP intolerance	2	0

Baseline Characteristics

Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Positive Airway Pressure n=26 Participants 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	Placebo n=13 Participants 2 weeks of oral administration of a placebo tablet 30min before bedtime	Total n=39 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 6.2 • n=5 Participants	55.2 years STANDARD_DEVIATION 8.4 • n=7 Participants	54.3 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	13 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 2

Population: One patient in the Placebo group who withdrew prior to any testing was excluded from the analysis.

The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline.

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure n=26 Participants 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	Placebo n=12 Participants 2 weeks of oral administration of a placebo tablet 30min before bedtime
Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2	-794.2 (mg/dL)*min Interval -1446.4 to -142.0	482.7 (mg/dL)*min Interval -422.2 to 1387.7

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: One patient from each group was excluded from the analysis since they were missing SI data at both Baseline and Week 2.

SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT). Change = Week 2 - Baseline.

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure n=25 Participants 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	Placebo n=12 Participants 2 weeks of oral administration of a placebo tablet 30min before bedtime
Change From Baseline in Insulin Sensitivity (SI) at Week 2	0.31 [mU/L]^-1·[min]^-1 Interval -0.11 to 0.74	-0.46 [mU/L]^-1·[min]^-1 Interval -1.07 to 0.15

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.

The average systolic blood pressure measured over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline.

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure n=22 Participants 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	Placebo n=10 Participants 2 weeks of oral administration of a placebo tablet 30min before bedtime
Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2	-1.9 mmHg Interval -6.2 to 2.3	7.6 mmHg Interval 1.9 to 13.3

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.

The average diastolic blood pressure over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure n=22 Participants 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	Placebo n=10 Participants 2 weeks of oral administration of a placebo tablet 30min before bedtime
Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2	-2.6 mmHg Interval -4.9 to -0.3	4.5 mmHg Interval 1.4 to 7.5

Adverse Events

Continuous Positive Airway Pressure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Esra Tasali

University of Chicago

Phone: 773-702-1497

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place