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

Trial Summary

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 data supports the effectiveness of the treatment Diabetes Prevention Program (DPP) for prediabetes?

The Diabetes Prevention Program (DPP) is shown to reduce the risk of developing type 2 diabetes by 58% over three years in people with prediabetes. This program focuses on lifestyle changes like diet and exercise, and has been supported by major health organizations. ^{1 2 3 4 5}

Is the Diabetes Prevention Program (DPP) safe for humans?

The Diabetes Prevention Program (DPP) is a lifestyle change program that has been evaluated in clinical trials and is supported by major health organizations like the American Medical Association and the Centers for Disease Control and Prevention, indicating it is generally safe for humans. ^{1 2 3 6 7}

How is the Diabetes Prevention Program (DPP) treatment different from other treatments for prediabetes?

The Diabetes Prevention Program (DPP) is unique because it focuses on lifestyle changes, such as diet and exercise, to prevent diabetes, rather than relying on medication or surgery. It has been shown to reduce the risk of developing diabetes by 58% over three years, making it a highly effective non-drug approach for people with prediabetes. ^{1 3 4 6 8}

What is the purpose of this trial?

Type 2 diabetes mellitus is one of the fastest growing public health problems in developed and developing countries and imposes a large financial burden on health-care systems. Preventing, delaying, and managing diabetes should be a priority for health-care systems. Nationally, 38% of adults have prediabetes, with more than 80% of people with prediabetes being unaware of their condition. In Maryland, an estimated 10.5% of adults report prediabetes, and 33.7% of Baltimore City residents have obesity, an important risk factor for prediabetes. The BMDRP aims to increase the capacity of BMDRP hospitals and community partners to offer DPP and DSMT directly in communities and will also increase the number of referrals into these programs. Successful enrollment and completion of DPP has demonstrated reduced risk of developing type 2 diabetes for individuals with pre-diabetes. However, limited data exist on changes in body composition and liver fat in individuals completing DPP. Individuals with pre-diabetes often have obesity and non-alcoholic fatty liver disease. We will evaluate for changes in body fat and liver fat in individuals completing the DPP program.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]

2. England 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). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. [2023]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Canada pubmed.ncbi.nlm.nih.gov

Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. [2022]