CPAP + Lifestyle Intervention for Prediabetes

(TECH Trial)

Overseen By Olivia Hughes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Diabetes, Formal weight loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a CPAP machine (a device that aids breathing during sleep) combined with diet and exercise coaching can better manage prediabetes and prevent diabetes. The goal is to determine if this combined approach improves heart and metabolic health more effectively than lifestyle changes alone. It is open to individuals who are overweight or obese, have prediabetes, and experience sleep apnea. Participants should not already have diabetes or be enrolled in a formal weight loss program. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative methods for diabetes prevention.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CPAP (continuous positive airway pressure) is generally safe for people with sleep apnea. It can help the body manage sugar better, and some individuals experience improved blood sugar levels with regular use. However, not all studies agree on its long-term effects on blood sugar control.

Regarding diet and exercise coaching, research indicates that these lifestyle changes can significantly reduce the risk of developing type 2 diabetes in people with prediabetes. Many participants in these programs lowered their diabetes risk by more than 50%. These changes are usually easy to follow and are often the first step recommended for managing prediabetes.

Overall, both CPAP and lifestyle changes appear safe according to existing studies. Prospective trial participants should discuss any concerns with a healthcare professional. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the CPAP plus lifestyle intervention for prediabetes because it combines two approaches in a unique way. Unlike standard treatments that typically focus only on diet and exercise changes, this intervention also incorporates CPAP therapy, which is traditionally used for sleep apnea. This combination targets both metabolic health through lifestyle adjustments and improves sleep quality and oxygen levels with CPAP, potentially enhancing insulin sensitivity more effectively. By addressing both sleep quality and lifestyle, this approach offers a comprehensive strategy that might lead to better outcomes for individuals with prediabetes.

What evidence suggests that CPAP treatment plus lifestyle intervention could be effective for prediabetes?

This trial will compare the effects of CPAP treatment combined with lifestyle changes to lifestyle changes alone. Studies have shown that using CPAP (a machine that aids breathing during sleep) for 8 hours each night can improve sugar metabolism in individuals with prediabetes. This suggests CPAP might help control blood sugar levels before diabetes develops. However, other research indicates that CPAP alone does not prevent diabetes onset in those with prediabetes. Still, CPAP is known to alleviate sleep apnea, a condition often linked with prediabetes. Therefore, combining CPAP with lifestyle changes like healthy eating and exercise might be more effective in improving overall health and reducing the risk of diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Esra Tasali, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CPAP Treatment
• Diet and exercise coaching

Trial Overview The 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.

How Is the Trial Designed?

Group I: Lifestyle Plus CPAP Intervention Experimental Treatment 2 Interventions

CPAP treatment, diet and exercise.

Group II: Lifestyle Intervention Experimental Treatment 1 Intervention

Diet and exercise.

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+

Published Research Related to This Trial

A combination of dietary changes, such as increasing lean proteins and vegetables while controlling carbohydrate portions, along with moderate-intensity exercise, can effectively lower metabolic risks associated with obesity and prevent the progression from prediabetes to diabetes.

This review emphasizes the importance of integrating both nutrition and physical activity as essential lifestyle modifications to combat obesity-related diabetes, highlighting their synergistic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Root Cause for Metabolic Syndrome and Type 2 Diabetes: Can Lifestyle and Nutrition Be the Answer for Remission. Gorodeski Baskin, R., Alfakara, D.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. Keck, JW., Thomas, AR., Hieronymus, L., et al.[2020]

A systematic review of 32 randomized controlled trials with 43,669 participants found that lifestyle modifications and metformin significantly reduce the risk of developing diabetes in adults with pre-diabetes, with an average relative risk reduction of 20%.

Lifestyle changes, including improved nutrition, increased exercise, and weight loss, not only help prevent diabetes but also lead to better overall health by reducing body weight, blood pressure, and blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Lifestyle Modification and Anti-diabetic Medicine on Prediabetes Progress: A Systematic Review and Meta-Analysis. Sheng, Z., Cao, JY., Pang, YC., et al.[2020]

In a study of 578 overweight/obese Asian Indian adults with prediabetes, a combination of lifestyle intervention and metformin reduced the incidence of diabetes by 32% over three years compared to standard lifestyle advice.

Most participants (72%) needed metformin in addition to lifestyle changes, indicating that while lifestyle interventions are effective, medication may be necessary for many individuals to achieve optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial. Weber, MB., Ranjani, H., Staimez, LR., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of lifestyle intervention in the reversion to normoglycemia in people with prediabetes. Liu, Y., Guo, H., Wang, Q., et al.[2022]

Intensive lifestyle interventions for individuals with prediabetes can lead to significant economic benefits, with estimated gross economic gains of $26,800 for those meeting ADA screening criteria over 10 years, which is higher than the average for the entire prediabetes population.

The analysis suggests that lifestyle interventions, similar to those in the Diabetes Prevention Program, are cost-effective, costing less than $2,300 over 10 years, while also providing substantial medical savings and improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of lifestyle intervention to prevent diabetes and sequelae. Dall, TM., Storm, MV., Semilla, AP., et al.[2022]

The Diabetes Prevention Program (DPP) and Look AHEAD trials provide crucial evidence for managing obesity, prediabetes, and type 2 diabetes through lifestyle interventions, with Look AHEAD featuring more ambitious weight-loss goals and structured nutrition strategies.

Insights from these trials will help shape future diabetes care and medical nutrition therapy, ensuring that effective strategies are implemented in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions. Delahanty, LM., Nathan, DM.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Lifestyle modifications, including both diet and exercise, are effective in reducing the risk of developing type 2 diabetes (T2D) and improving blood sugar control in adults with prediabetes, even without significant weight loss.

The specific contributions of diet or exercise alone to glycemic control and weight loss in prediabetes remain unclear, indicating a need for further research to determine the most effective strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent and combined effect of diet and exercise in adults with prediabetes. Sénéchal, M., Slaght, J., Bharti, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4511421/

Eight Hours of Nightly Continuous Positive Airway ... In patients with prediabetes, 8-hour nightly CPAP treatment for 2 weeks improves glucose metabolism compared with placebo.

2. academic.oup.com academic.oup.com/jcem/article/97/11/4212/2836645

Effect of Continuous Positive Airway Pressure Therapy on ... Continuous positive airway pressure (CPAP) therapy is effective treatment for OSA, and available data suggest that it may improve CVD risk factors in diabetic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8029513/

Effect of 12‐week continuous positive airway pressure therapy ... CPAP treatment for 12 weeks does not significantly change glycaemic control in patients with type 2 diabetes and OSA.

4. diabetesjournals.org diabetesjournals.org/care/article/43/8/1859/35584/Continuous-Positive-Airway-Pressure-Treatment

Continuous Positive Airway Pressure Treatment, Glycemia ... CPAP treatment did not prevent the onset of diabetes in participants with prediabetes at enrollment, and consistent with previously reported ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01156116

Effective Treatment of Sleep Apnea in Prediabetes to ... The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. Detailed ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32291275/

Continuous Positive Airway Pressure Treatment, Glycemia, ... We found no evidence that CPAP therapy over several years affects glycemic control in those with diabetes or prediabetes or diabetes risk over standard-of-care ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01503164

Effects of Continuous Positive Airway Pressure (CPAP) on ... The primary hypothesis of this study is that PAP therapy of obstructive sleep apnea will improve in insulin sensitivity and glucose metabolism. Detailed ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/486425

Type 2 Diabetes, Glycemic Control, and Continuous ... There was a strong and significant correlation between days of CPAP use and HbA1c improvement in compliant CPAP users but not in noncompliant users (Figure 3).

9. archbronconeumol.org archbronconeumol.org/en-effect-continuous-positive-airway-pressure-articulo-S0300289623001114

Effect of Continuous Positive Airway Pressure on Glucose ... CPAP treatment may improve insulin sensitivity and total cholesterol levels in OSA patients but with low effect size.