Trial Outcomes & Findings for Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes (NCT NCT01136785)

Results Overview

24 hour blood sampling will be performed at baseline and at the end of the 7-day intervention. Glucose levels will be measured on each sample. Mean glucose level for all baseline samples will be calculated for each participant. Mean glucose levels for all samples collected at the end of the intervention will be calculated. Change in mean glucose level from baseline to end of intervention will be calculated for each participant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

after 1 week of CPAP therapy in the laboratory

Results posted on

2017-04-10

Participant Flow

In a 2:1 ratio (2 active CPAP: 1 sham CPAP), 22 eligible subjects who had completed baseline assessments underwent 1 week of in-laboratory active CPAP or sham CPAP therapy and completed the post-treatment assessments. Two subjects assigned to the CPAP group and one subject assigned to the sham group were excluded for protocol violations.

Participant milestones

Participant milestones
Measure	Active CPAP 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP 7 days of sham CPAP in the laboratory.
Overall Study STARTED	15	7
Overall Study COMPLETED	13	6
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active CPAP 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP 7 days of sham CPAP in the laboratory.
Overall Study Protocol Violation	2	1

Baseline Characteristics

Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active CPAP n=13 Participants 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP n=6 Participants 7 days of sham CPAP in the laboratory.	Total n=19 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	52.3 years STANDARD_DEVIATION 3.1 • n=7 Participants	55.0 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: after 1 week of CPAP therapy in the laboratory

24 hour blood sampling will be performed at baseline and at the end of the 7-day intervention. Glucose levels will be measured on each sample. Mean glucose level for all baseline samples will be calculated for each participant. Mean glucose levels for all samples collected at the end of the intervention will be calculated. Change in mean glucose level from baseline to end of intervention will be calculated for each participant.

Outcome measures

Outcome measures
Measure	Active CPAP n=13 Participants 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP n=6 Participants 7 days of sham CPAP in the laboratory.
Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling	-13.7 mg/dl Standard Error 3.6	-2.9 mg/dl Standard Error 1.4

PRIMARY outcome

Timeframe: change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory

Population: Due to sensor failures, valid profiles of interstitial glucose were available in 10 participants with the active CPAP group and 4 participants in the sham CPAP group.

Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy. The mean glucose level of all samples collected at baseline will be calculated for each participant. The mean glucose level of all samples collected at the end of the 7-day intervention will be calculated for each participant. For each participant, we will calculate the change in mean glucose level from baseline till end of the intervention.

Outcome measures

Outcome measures
Measure	Active CPAP n=10 Participants 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP n=4 Participants 7 days of sham CPAP in the laboratory.
Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours	-12.4 mg/dL Standard Error 3.9	1.5 mg/dL Standard Error 2.2

PRIMARY outcome

Timeframe: after 1 week of therapy in the laboratory

Serum insulin levels will be measured on each sample collected during 24-h sampling at baseline and at the end of the 7-day intervention. Mean insulin level over 24 hours will be calculated for each participant at baseline and at the end of the intervention. For each participant, we will calculate the change in mean insulin level from baseline.

Outcome measures

Outcome measures
Measure	Active CPAP n=13 Participants 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP n=6 Participants 7 days of sham CPAP in the laboratory.
Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling	-25.8 pmol/L Standard Error 16.5	28.4 pmol/L Standard Error 21.6

SECONDARY outcome

Timeframe: after 1 week of active CPAP therapy in the laboratory

The mean plasma cortisol level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.

Outcome measures

Outcome measures
Measure	Active CPAP n=12 Participants 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP 7 days of sham CPAP in the laboratory.
Change in Mean Plasma Cortisol Level From 24-h Sampling	-0.1 microgram/dL Interval -0.8 to 0.7	—

SECONDARY outcome

Timeframe: after 1 week of active CPAP therapy in the laboratory

The mean plasma growth hormone level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.

Outcome measures

Outcome measures
Measure	Active CPAP n=12 Participants 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP 7 days of sham CPAP in the laboratory.
24-hr Profile of Plasma Growth Hormone	-0.02 ng/ml Interval -0.15 to 0.04	—

SECONDARY outcome

Timeframe: after 1 week of active CPAP therapy in the laboratory

The mean plasma norepinephrine level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean norepinephine level from baseline to end of intervention will be calculated.

Outcome measures

Outcome measures
Measure	Active CPAP n=8 Participants 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea	Sham CPAP 7 days of sham CPAP in the laboratory.
Change in 24-h Mean Level of Plasma Norepinephrine	-60.9 pg/ml Interval -124.7 to -6.2	—

Adverse Events

Active CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham CPAP

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

Dr. Eve Van Cauter/Dr. Babak Mokhlesi

The University of Chicago

Phone: 773-702-0169 or 773-702-2181

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place