Trial Outcomes & Findings for Effects of Treatment of Sleep Apnea on Metabolic Syndrome (NCT NCT01385995)

NCT ID: NCT01385995

Last Updated: 2014-03-12

Results Overview

Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose\< 140 mg/dL)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 20 weeks
• Results posted on: 2014-03-12

Participant Flow

Participant milestones

Measure	Continuous Positive Airway Pressure (CPAP)	Sham-Continuous Positive Airway Pressure
Period 1, 2 Months STARTED	25	25
Period 1, 2 Months COMPLETED	24	25
Period 1, 2 Months NOT COMPLETED	1	0
Washout Period, 1 Month STARTED	24	25
Washout Period, 1 Month COMPLETED	24	25
Washout Period, 1 Month NOT COMPLETED	0	0
Period 2, 2 Months STARTED	24	25
Period 2, 2 Months COMPLETED	24	25
Period 2, 2 Months NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Continuous Positive Airway Pressure (CPAP)	Sham-Continuous Positive Airway Pressure
Period 1, 2 Months Physician Decision	1	0

Baseline Characteristics

Effects of Treatment of Sleep Apnea on Metabolic Syndrome

Baseline characteristics by cohort

Measure	Continuous Positive Airway Pressure (CPAP) n=25 Participants	Sham-Continuous Positive Airway Pressure n=25 Participants	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 10 • n=5 Participants	53 years STANDARD_DEVIATION 8 • n=7 Participants	53.6 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 20 weeks

Population: All available oral glucose tolerance test data was analyzed for the total sample.

Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL)

Outcome measures

Measure	Therapeutic CPAP n=47 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.	Sham CPAP n=47 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)	7 subjects	5 subjects

SECONDARY outcome

Timeframe: 20 weeks

Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)

Outcome measures

Measure	Therapeutic CPAP n=50 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.	Sham CPAP n=49 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham Fasting Glucose (mg/dL), CPAP	106.4 mg/dL Standard Deviation 12.4 • Interval -1.2 to 3.0	105.6 mg/dL Standard Deviation 13.3
Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham 2-Hour OGTT (mg/dL), CPAP	171.1 mg/dL Standard Deviation 43.5 • Interval -16.3 to 1.7	178.2 mg/dL Standard Deviation 48.5

SECONDARY outcome

Timeframe: 20 weeks

Population: All subjects with available fasting and and 2-hour insulin measurements are included.

The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.

Outcome measures

Measure	Therapeutic CPAP n=50 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.	Sham CPAP n=46 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham Fasting Insulin (iIU/dL)	16.4 iIU/dL Standard Deviation 9.0 • Interval -3.4 to 0.5	17.2 iIU/dL Standard Deviation 10.1
Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham 2-Hour OGTT Insulin (iU/dL)	110.1 iIU/dL Standard Deviation 60.7 • Interval -23.3 to 2.8	114.3 iIU/dL Standard Deviation 68.1

SECONDARY outcome

Timeframe: 20 weeks

Population: All subjects with available fasting insulin, glucose measurements

Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP

Outcome measures

Measure	Therapeutic CPAP n=50 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.	Sham CPAP n=46 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham	4.4 percentage of beta cell function Standard Deviation 2.6 • Interval -17.6 to 1.8	4.6 percentage of beta cell function Standard Deviation 3.0

SECONDARY outcome

Timeframe: 20 Weeks

Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity.

Outcome measures

Measure	Therapeutic CPAP n=49 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.	Sham CPAP n=46 Participants Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham	12 units on a scale Standard Deviation 3.3	12 units on a scale Standard Deviation 3.8

Adverse Events

Continuous Positive Airway Pressure (CPAP)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Sham-Continuous Positive Airway Pressure

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuous Positive Airway Pressure (CPAP) n=50 participants at risk	Sham-Continuous Positive Airway Pressure n=50 participants at risk
Respiratory, thoracic and mediastinal disorders Chest Pain (non cardiac)	2.0% 1/50 • Number of events 1 • 6 months	0.00% 0/50 • 6 months

Other adverse events

Measure	Continuous Positive Airway Pressure (CPAP) n=50 participants at risk	Sham-Continuous Positive Airway Pressure n=50 participants at risk
Skin and subcutaneous tissue disorders skin irritation from nasal CPAP mask	12.0% 6/50 • Number of events 6 • 6 months	4.0% 2/50 • Number of events 2 • 6 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 2/50 • Number of events 2 • 6 months	4.0% 2/50 • Number of events 2 • 6 months
Eye disorders Eye irritation	2.0% 1/50 • Number of events 1 • 6 months	0.00% 0/50 • 6 months
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	2.0% 1/50 • Number of events 1 • 6 months	2.0% 1/50 • Number of events 1 • 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Boil on Lip	2.0% 1/50 • Number of events 1 • 6 months	0.00% 0/50 • 6 months
Social circumstances Drowsy Driving	0.00% 0/50 • 6 months	2.0% 1/50 • Number of events 1 • 6 months
Psychiatric disorders Claustrophobia	0.00% 0/50 • 6 months	2.0% 1/50 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Skin irritation from echocardiogram leads	2.0% 1/50 • Number of events 1 • 6 months	0.00% 0/50 • 6 months
Ear and labyrinth disorders Ear Pain	2.0% 1/50 • Number of events 1 • 6 months	0.00% 0/50 • 6 months

Additional Information

Dr. Susan Redline

Brigham and Women's Hospital

Phone: 857-307-0352

Email: sredline1@rics.bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place