Diabetes Prevention Program + INSPIRA for Prediabetes

(INSPIRA Trial)

Overseen By Shelley Stoll, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Schizophrenia, Drug abuse, Pregnancy, others

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

Compensation: Varies

Number of Visits: 16

Duration: 24 weeks

142 Participants Needed

Trial Summary

What is the purpose of this trial?

This research is studying how to help increase uptake of and engagement in formal Diabetes Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce risk of getting diabetes. This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program includes getting matched with someone else in the program to provide each other support along with a chance to earn healthy food vouchers. Eligible participants will be randomized to one of the two groups and be asked to participate for approximately 6 months.

Do I need to stop my current medications to join the trial?

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

What data supports the effectiveness of the Diabetes Prevention Program + INSPIRA treatment 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, according to research supported by the American Medical Association and the Centers for Disease Control and Prevention. ^{1 2 3 4 5}

Is the Diabetes Prevention Program safe for humans?

The Diabetes Prevention Program (DPP) is a well-established lifestyle change program that has been tested in a large clinical trial setting, indicating it is generally safe for humans. ^{1 2 3 6 7}

How is the Diabetes Prevention Program + INSPIRA treatment different from other treatments for prediabetes?

The Diabetes Prevention Program + INSPIRA is unique because it is a lifestyle change program specifically designed to prevent or delay the onset of type 2 diabetes in people with prediabetes, showing a 58% reduction in diabetes incidence over three years. Unlike typical drug treatments, it focuses on lifestyle modifications such as diet and exercise, and is supported by major health organizations like the American Medical Association and the Centers for Disease Control and Prevention. ^{1 2 3 6 7}

Research Team

Mary Ellen M Heisler, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults with prediabetes, specifically those who have a BMI over 24.9 and an A1c level between 5.7%-6.4%. Participants must be able to attend sessions in English or Spanish and commit to the local area for six months. It's not suitable for individuals with active substance abuse, schizophrenia, or those pregnant or planning pregnancy soon.

Inclusion Criteria

Your most recent A1c test taken in the last 60 days shows a result between 5.7% and 6.4%.

I speak English or Spanish.

You weigh more than what is considered healthy for your height.

Exclusion Criteria

I cannot attend sessions, either in-person or online, for the next three weeks.

Will not be in local area in six months

Are pregnant or planning pregnancy in next 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Diabetes Prevention Program (DPP) with or without additional INSPIRA interventions for 6 months

24 weeks

16 weekly group sessions

Follow-up

Participants are monitored for changes in weight, waist circumference, and diet quality

4 weeks

Treatment Details

Interventions

• Diabetes Prevention Program
• INSPIRA

Trial Overview The study compares two approaches: the standard Diabetes Prevention Program (DPP) versus DPP plus INSPIRA, which includes peer support and healthy food vouchers as incentives. Participants will be randomly assigned to one of these groups for about half a year.

Participant Groups

Group I: DPP plus the INSPIRA intervention Experimental Treatment 2 Interventions

This arm will include the DPP plus additional interventions.

Group II: Diabetes Prevention Program (DPP) (usual care) Active Control 1 Intervention

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

Approved in United States as National Diabetes Prevention Program (NDPP) for:

• Prediabetes
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Findings from Research

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) 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 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]

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]

The Diabetes Prevention Program (DPP) effectively identified high-risk adults for type 2 diabetes, with 27% of participants showing impaired glucose tolerance and 13% having previously undiagnosed diabetes based on oral glucose tolerance tests (OGTT).

Fasting capillary glucose levels, along with age and BMI, significantly improved the screening process for high-risk individuals across various ethnic groups, suggesting it can enhance the efficiency of diabetes prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]

The Diabetes Prevention Program (DPP) is a large-scale clinical trial aimed at preventing type 2 diabetes in high-risk individuals, with 3,048 participants recruited from a pool of over 133,000 screened, highlighting its extensive reach.

The trial includes diverse participants, with 45% from ethnic minority groups and 67% being women, ensuring a representative sample for evaluating the effectiveness of lifestyle changes and metformin in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Background and recruitment data for the U.S. Diabetes Prevention Program. Fujimoto, WY.[2018]

References

1. 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]

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. [2022]

5. 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]

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

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]

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

Background and recruitment data for the U.S. Diabetes Prevention Program. [2018]