Technology-Supported Treatment of Sleep Apnea in Prediabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 182
- Locations
- 2
- Primary Endpoint
- Change from baseline 2-hour glucose levels at 6 months
Study Overview
Brief Summary
Despite the efficacy of intensive lifestyle interventions in prediabetes, the incidence of diabetes is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications in this high-risk population. Sleep apnea is a highly common condition in prediabetes, but it has been mostly ignored and undertreated in current practice. The proposed study will be the first to assess whether adding CPAP (continuous positive air pressure) treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in high-risk individuals with prediabetes.
Detailed Description
This is a 6-month randomized controlled, parallel group trial with two arms. After baseline, the subjects will be randomized to lifestyle intervention alone (lifestyle group) or lifestyle plus CPAP intervention (lifestyle plus CPAP group). The same metabolic and cardiovascular assessments will be performed at baseline and after 6-months of intervention.
The lifestyle group will aim to achieve a weight loss through diet and exercise. The lifestyle plus CPAP group will additionally receive CPAP treatment. All subjects will use a custom smartphone app to track weight loss and/or CPAP goals and will receive weekly coaching phone calls to maximize treatment adherence.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Overweight or obese
- Prediabetes
- Sleep apnea
Exclusion Criteria
- Diabetic
- enrolled in a formal weight loss program
- Any underlying disease likely to limit life span and/or increase risk of interventions
Arms & Interventions
Lifestyle Intervention
Diet and exercise.
Intervention: Diet and exercise coaching (Behavioral)
Lifestyle Plus CPAP Intervention
CPAP treatment, diet and exercise.
Intervention: Diet and exercise coaching (Behavioral)
Lifestyle Plus CPAP Intervention
CPAP treatment, diet and exercise.
Intervention: CPAP Treatment (Other)
Outcomes
Primary Outcomes
Change from baseline 2-hour glucose levels at 6 months
Time Frame: Baseline and at 6 months
Glucose levels will be measured at time=120min during oral glucose tolerance test
Secondary Outcomes
- Change from baseline morning blood pressure at 6 months(Baseline and 6 months)
Investigators
Study Sites (2)
Identifiers
- NCT ID
- NCT04225507
- Other Study IDs
- IRB19-1445, R01DK120312
Dates
- First Submitted
- (6 years ago)
- First Posted
- (6 years ago)
- Primary Completion
- (2 months ago)
- Study Completion
- (2 months ago)
- Last Verified
- (29 days ago)
- Last updated
- (2 days ago)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No