174 Participants Needed

CPAP + Lifestyle Intervention for Prediabetes

(TECH Trial)

ET
OH
Overseen ByOlivia Hughes
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of CPAP + Lifestyle Intervention for Prediabetes?

Research shows that lifestyle changes, including diet and exercise, can effectively delay or prevent the progression of prediabetes to diabetes. Additionally, dietary coaching has been shown to improve eating habits and health outcomes in people with prediabetes.12345

Is CPAP + Lifestyle Intervention safe for humans?

Lifestyle interventions, including diet and exercise, are generally safe and recommended for people at risk of type 2 diabetes. They have been shown to improve health outcomes without significant safety concerns. However, specific safety data for CPAP (Continuous Positive Airway Pressure) in combination with lifestyle interventions for prediabetes is not detailed in the provided research.23678

How does the CPAP + Lifestyle Intervention treatment for prediabetes differ from other treatments?

The CPAP + Lifestyle Intervention treatment is unique because it combines continuous positive airway pressure (CPAP) therapy, which is typically used for sleep apnea, with lifestyle changes like diet and exercise coaching. This approach not only targets blood sugar levels but also addresses sleep quality, which can indirectly improve eating habits and overall health outcomes.23459

Research Team

ET

Esra Tasali, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for overweight or obese individuals who have prediabetes and sleep apnea. It's not open to those with diabetes, currently in a weight loss program, or with diseases that could shorten life or make the treatments risky.

Inclusion Criteria

I have been diagnosed with prediabetes.
You are too heavy for this study.
I have been diagnosed with sleep apnea.

Exclusion Criteria

I do not have any health conditions that could shorten my life or make treatments risky.
You are currently in a weight loss program.
I have diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either lifestyle intervention alone or lifestyle plus CPAP intervention for 6 months

6 months
Weekly coaching phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • CPAP Treatment
  • Diet and exercise coaching
Trial OverviewThe study tests if adding CPAP treatment to lifestyle changes like diet and exercise can better improve heart health and prevent diabetes in people at high risk due to prediabetes than lifestyle changes alone.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Lifestyle Plus CPAP InterventionExperimental Treatment2 Interventions
CPAP treatment, diet and exercise.
Group II: Lifestyle InterventionExperimental Treatment1 Intervention
Diet and exercise.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Northwestern University

Collaborator

Trials
1,674
Recruited
989,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

A lifestyle intervention strategy, including exercise, diet, and peer education, was effective in reversing prediabetes to normal blood glucose levels in 36.7% of participants, compared to 34.5% in the control group who received general health education.
The intervention group showed a significantly greater reduction in waist circumference and fasting plasma glucose levels, with an odds ratio of 1.32 indicating a higher likelihood of achieving normoglycemia after the intervention.
Short-term effects of lifestyle intervention in the reversion to normoglycemia in people with prediabetes.Liu, Y., Guo, H., Wang, Q., et al.[2022]
A 4-week randomized controlled study with 45 patients showed that dietary coaching combined with continuous glucose monitoring (CGM) significantly improved health outcomes, such as reduced thigh circumference in men.
Women in the experimental group experienced greater improvements in eating self-efficacy compared to the control group, indicating that dietary coaching can enhance behavioral skills related to eating habits.
Effectiveness of Non-Contact Dietary Coaching in Adults with Diabetes or Prediabetes Using a Continuous Glucose Monitoring Device: A Randomized Controlled Trial.Ahn, YC., Kim, YS., Kim, B., et al.[2023]
Clinicians recognize the importance of prediabetes screening and diagnosis, with 93.7% acknowledging it as a significant health issue, yet only 45.2% are familiar with the National Diabetes Prevention Program (DPP).
Despite high screening rates (75.9%) for diabetes among eligible patients, only 50.7% of those diagnosed with prediabetes had their condition documented, and no patients were referred to a DPP, indicating a gap in the implementation of lifestyle change programs.
Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice.Keck, JW., Thomas, AR., Hieronymus, L., et al.[2020]

References

Short-term effects of lifestyle intervention in the reversion to normoglycemia in people with prediabetes. [2022]
Effectiveness of Non-Contact Dietary Coaching in Adults with Diabetes or Prediabetes Using a Continuous Glucose Monitoring Device: A Randomized Controlled Trial. [2023]
Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. [2020]
The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial. [2022]
Effects of Lifestyle Modification and Anti-diabetic Medicine on Prediabetes Progress: A Systematic Review and Meta-Analysis. [2020]
Value of lifestyle intervention to prevent diabetes and sequelae. [2022]
Independent and combined effect of diet and exercise in adults with prediabetes. [2022]
Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions. [2022]
Root Cause for Metabolic Syndrome and Type 2 Diabetes: Can Lifestyle and Nutrition Be the Answer for Remission. [2023]