Technology-Supported Treatment of Sleep Apnea in Prediabetes

NCT04225507 | Active Not Recruiting DMC

• 2 other identifiers: IRB19-1445R01DK120312
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obesity; Sleep Apnea; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline morning blood pressure at 6 months

  Baseline and 6 months

Study Arms (2)

Lifestyle Intervention

OTHER

Diet and exercise.

Behavioral: Diet and exercise coaching

Lifestyle Plus CPAP Intervention

EXPERIMENTAL

CPAP treatment, diet and exercise.

Behavioral: Diet and exercise coaching; Other: CPAP Treatment

Interventions

Diet and exercise coaching BEHAVIORAL

All participants will receive diet and exercise goals and coaching.

Lifestyle Intervention; Lifestyle Plus CPAP Intervention

CPAP Treatment OTHER

CPAP treatment for sleep apnea and CPAP education and adherence coaching.

Lifestyle Plus CPAP Intervention

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight or obese
• Prediabetes
• Sleep apnea

You may not qualify if:

• Diabetic
• enrolled in a formal weight loss program
• Any underlying disease likely to limit life span and/or increase risk of interventions

Sponsors & Collaborators

• University of Chicago: lead
• Northwestern University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Prediabetic State; Overweight; Obesity

Interventions

Diet; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Esra Tasali, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: April 13, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-07

Locations

US (1)