Technology-Supported Treatment of Sleep Apnea in Prediabetes

PreDiabetes Clinical Trial

— TECH  

Official title:

Technology-Supported Treatment of Sleep Apnea in Prediabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04225507
• Other study ID #: IRB19-1445
• Secondary ID: R01DK120312
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 740
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Glucose Intolerance
• Overweight
• Overweight or Obesity
• PreDiabetes
• Prediabetic State
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Behavioral:
• Diet and exercise coaching
All participants will receive diet and exercise goals and coaching.

Other:
• CPAP Treatment
CPAP treatment for sleep apnea and CPAP education and adherence coaching.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline 2-hour glucose levels at 6 months	Glucose levels will be measured at time=120min during oral glucose tolerance test	Baseline and at 6 months
Secondary	Change from baseline morning blood pressure at 6 months	Morning blood pressure will be measured with a blood pressure cuff while sitting	Baseline and 6 months