Diabetes Prevention & Education for Prediabetes

Overseen By Kashif Munir, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Normoglycemia

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively a lifestyle program can prevent type 2 diabetes in individuals with prediabetes. The focus is on whether this program can alter body fat and liver fat levels, common issues for those with prediabetes. Participants will join the Diabetes Prevention Program (DPP), which has shown promise in reducing the risk of developing type 2 diabetes. Individuals with prediabetes and a higher-than-normal body mass index (BMI) may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could significantly impact diabetes prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Diabetes Prevention Program (DPP) is safe?

Research shows that the Diabetes Prevention Program (DPP) is both safe and effective. Studies have found that this program can reduce the risk of developing type 2 diabetes by 58%. Participants in the DPP have not reported major safety issues or side effects. The program emphasizes healthy lifestyle changes, which are generally safe for most people.

Additionally, the Diabetes Self-Management Training (DSMT) is another safe method. It helps people manage diabetes by teaching them about healthy eating, staying active, and checking blood sugar levels. This program has improved quality of life and health outcomes without causing harm.

Both programs have strong safety records, making them reliable options for those looking to prevent or manage diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Prevention Program (DPP) for prediabetes because it focuses on lifestyle changes rather than medication. Unlike standard treatments that often rely on drugs such as metformin to manage blood sugar, DPP emphasizes personalized interventions like diet and exercise, which can lead to sustainable long-term health improvements. Additionally, the program includes advanced body composition and liver fat analyses to tailor interventions more effectively and monitor progress, providing a more comprehensive approach to diabetes prevention.

What evidence suggests that the Diabetes Prevention Program (DPP) is effective for preventing type 2 diabetes in individuals with prediabetes?

Research has shown that the Diabetes Prevention Program (DPP) effectively reduces the risk of developing type 2 diabetes. Participants in the DPP Lifestyle Change Program lowered their risk by 58%. This program includes lifestyle changes, such as losing 5 to 7% of body weight, which have consistently improved health outcomes. The program works best in face-to-face settings, where participants tend to lose more weight and become more physically active. Participants in this trial will receive body composition analysis and liver fat analysis before, during, and after the lifestyle intervention. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with prediabetes, obesity, or type 2 diabetes who want to prevent or manage their condition. Participants should have a BMI of at least 25 (or 23 if Asian) indicating overweight status. Those with normal blood sugar levels are not eligible.

Inclusion Criteria

I have type 2 diabetes.

I am pre-diabetic with a BMI of 25 or higher, or 23 if I'm Asian.

Exclusion Criteria

Your blood sugar levels are normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

Participants undergo the Diabetes Prevention Program (DPP) lifestyle intervention, which includes body composition and liver fat analysis

12 months

Regular visits for body composition and liver fat analysis

Follow-up

Participants are monitored for changes in liver elastography, body composition, and diabetes control after completing the DPP

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Prevention Program (DPP)
• Diabetes Self-Management Training (DSMT)

Trial Overview The trial tests the Diabetes Prevention Program (DPP) and Diabetes Self-Management Training (DSMT). It aims to see if these programs can reduce the risk of developing type 2 diabetes and improve body composition and liver health in participants.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

All subjects participating in the diabetes prevention program will be offered body composition analysis and liver fat analysis, before, during, and after the lifestyle intervention

Diabetes Prevention Program (DPP) is already approved in United States for the following indications:

Approved in United States as Diabetes Prevention Program for:

• Prediabetes
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

The Veterans Affairs Diabetes Prevention Program (VA-DPP) showed higher fidelity in delivery compared to the usual MOVE! program, indicating it may be more effectively implemented in clinical settings.

Participant satisfaction was generally higher in the VA-DPP, suggesting that this program not only has better implementation but also resonates more positively with participants, which is crucial for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA). Damschroder, LJ., Reardon, CM., AuYoung, M., et al.[2022]

The Intensive Lifestyle Intervention (ILI) in the Diabetes Prevention Program (DPP) effectively helped approximately 3800 high-risk adults with prediabetes achieve weight loss through dietary and exercise modifications, demonstrating a practical approach to delaying or preventing type 2 diabetes.

The DPP and its follow-up, the DPP Outcomes Study (DPPOS), highlight the importance of lifestyle changes in managing prediabetes, particularly in a diverse population, suggesting that these interventions can be tailored to various ethnic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. Hoskin, MA., Bray, GA., Hattaway, K., et al.[2019]

A pilot study involving 92 participants showed that a group-based lifestyle intervention delivered by the YMCA led to a significant 6.0% reduction in body weight after 6 months, compared to only a 2.0% reduction in the control group.

The intervention also resulted in a notable decrease in total cholesterol levels, with a reduction of 22 mg/dL in the intervention group versus an increase of 6 mg/dL in controls, indicating the program's effectiveness in improving health markers associated with diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Ackermann, RT., Finch, EA., Brizendine, E., et al.[2022]

A randomized clinical trial involving 257 obese patients with metabolic syndrome showed that a group conference call (CC) intervention led to significantly greater weight loss (-5.6%) compared to individual calls (IC) (-1.8%) over 2 years, indicating that group support may enhance weight loss outcomes.

Participants in the CC group not only lost more weight but also continued to lose weight between the first and second year, while those in the IC group began to regain weight, highlighting the importance of ongoing support in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. Weinstock, RS., Trief, PM., Cibula, D., et al.[2022]

In a modified Diabetes Prevention Program (DPP) for patients with non-alcoholic fatty liver disease (NAFLD), 79% of participants completed the program, leading to significant weight loss and improvements in liver health indicators over 12 months.

Key improvements included reduced hepatic steatosis and liver enzymes, indicating enhanced liver function, although there was a noted increase in low-density lipoprotein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Hershman, M., Torbjornsen, K., Pang, D., et al.[2023]

The Diabetes Prevention Program (DPP) is a large clinical trial involving 3,234 participants aimed at evaluating interventions to prevent type 2 diabetes in individuals at high risk, with a diverse demographic including various ethnic backgrounds and age groups.

The study will assess the effectiveness of three treatment approaches: intensive lifestyle modification, standard care with metformin, and standard care with placebo, to determine their impact on delaying or preventing diabetes development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

A mobile-delivered version of the CDC's diabetes prevention program (DPP) led to significant weight loss in adults with prediabetes, with participants losing an average of 2.64 kg at 6 months compared to the control group, which showed no meaningful weight change.

While the mobile DPP did not significantly lower hemoglobin A1c (HbA1c) levels compared to usual care, it demonstrated a reduction in HbA1c levels over a year, indicating potential long-term benefits in diabetes risk reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. Toro-Ramos, T., Michaelides, A., Anton, M., et al.[2022]

Citations

1. niddk.nih.gov niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp

Diabetes Prevention Program (DPP) - NIDDK After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

2. cdc.gov cdc.gov/diabetes-prevention/programs/what-is-the-national-dpp.html

What Is the National DPP? | National Diabetes Prevention ... Results from the study showed that this structured lifestyle change program—in which participants achieved weight loss of 5 to 7 percent of ...

3. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

4. coveragetoolkit.org coveragetoolkit.org/about-national-dpp/evidence/

Evidence Research studies and evaluations have repeatedly shown that interventions such as the National DPP lifestyle change program improve health outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0168822723005983

Uptake, retention, and outcomes of the National Diabetes ... In-person classroom-based programs had better retention and were associated with more weight loss and physical activity than the virtual program.

6. cdc.gov cdc.gov/diabetes-prevention/index.html

National Diabetes Prevention Program The National Diabetes Prevention Program is building a nationwide network for its lifestyle change program, which is proven to cut type 2 diabetes risk in half.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00004992

Study Details | NCT00004992 | Diabetes Prevention Program Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes.