Overweight or Obesity, PreDiabetes, Sleep Apnea
Conditions
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.
Interventions
BEHAVIORALDiet and exercise coaching
All participants will receive diet and exercise goals and coaching.
OTHERCPAP Treatment
CPAP treatment for sleep apnea and CPAP education and adherence coaching.
Sponsors
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline 2-hour glucose levels at 6 months | Baseline and at 6 months | Glucose levels will be measured at time=120min during oral glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline morning blood pressure at 6 months | Baseline and 6 months | Morning blood pressure will be measured with a blood pressure cuff while sitting |
Countries
United States
Outcome results
None listed