Tailored DPP Intervention for Prediabetes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Not UCLA undergrad, Not T-UP eligible

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

Compensation: Varies

Number of Visits: 21

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a tailored Diabetes Prevention Program (DPP) to help young adults at risk of type 2 diabetes achieve healthy weight loss. It specifically targets students facing challenges like food or financial insecurity. Participants are divided into two groups: one receives the specialized DPP sessions, while the other receives educational materials on study habits, alcohol use, and financial literacy. The trial seeks to determine if this customized approach is practical and well-received. Eligible participants are UCLA undergraduates with a BMI of 25 or higher (23 or higher for those identifying as Asian) and prediabetes or a high risk of developing diabetes. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future 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 this intervention is safe for young adults?

Research has shown that the Diabetes Prevention Program (DPP) is generally safe. In past studies, the DPP significantly lowered the risk of developing type 2 diabetes. Specifically, participants who adopted lifestyle changes through the program reduced their diabetes risk by 58%. This suggests the program is well-tolerated, as it emphasizes healthy habits instead of medication.

These studies reported no serious side effects. The DPP typically includes activities like eating healthier and exercising more, which are safe and beneficial for most people. These findings indicate that the personalized DPP approach should be safe for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tailored Diabetes Prevention Program (DPP) because it offers a personalized approach to combating prediabetes, unlike standard lifestyle interventions that often follow a one-size-fits-all model. This tailored intervention adapts to the individual needs of participants, potentially enhancing engagement and effectiveness. By focusing on personalized strategies for diet, exercise, and behavior change, the DPP aims to better address the unique challenges faced by each person, which could lead to more successful prevention of diabetes progression.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that the Diabetes Prevention Program (DPP), which participants in this trial may receive, effectively lowers the risk of developing type 2 diabetes. One study found that lifestyle changes in the DPP reduced the chance of getting type 2 diabetes by 58%. The program emphasizes changes in diet and exercise, crucial for managing weight and blood sugar. Tailoring the DPP to fit different cultural and economic backgrounds can enhance its success. These adjustments help overcome challenges that might otherwise limit the program's effectiveness. Overall, the DPP offers a promising way to prevent diabetes, especially when tailored to individual needs. ^{1 3 6 7 8}

Who Is on the Research Team?

Lauren Wisk, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for young adults at risk of type 2 diabetes, particularly those who are underserved and dealing with challenges like food and financial insecurity. Participants should be students willing to engage in a program aimed at preventing diabetes.

Inclusion Criteria

Participants who are currently enrolled (either full time or part time) as an undergraduate at UCLA and meet criteria for the T-UP Wellness Program (students who have a BMI of ≥25 (≥23 for those self-identifying as Asian) and either documented prediabetes or identified as high-risk on a CDC questionnaire)

Exclusion Criteria

Participants who are not currently enrolled (either full time or part time) as an undergraduate at UCLA and do not meet criteria for the T-UP Wellness Program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AYA-tailored Diabetes Prevention Program intervention, including 19 sessions over the academic year

9 months

18 in-person sessions, 1 on-demand session

Control

Control group receives materials on study habits, alcohol use, and financial literacy via email, with Zoom sessions for explanation

9 months

3 Zoom sessions

Follow-up

Participants are monitored for changes in weight and quality of life at 9-month follow-up

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Tailored DPP Intervention

Trial Overview

The study tests a tailored version of the UC Diabetes Prevention Program (DPP) designed for adolescents and young adults. It involves group sessions led by lifestyle coaches over nine months, aiming to reduce diabetes risk through weight loss.

How Is the Trial Designed?

Group I: Diabetes Prevention Program (DPP) group Experimental Treatment 1 Intervention

The DPP group will receive a tailored Diabetes Prevention Program.

Group II: Control group Active Control 1 Intervention

The control group will receive access to materials on study habits (fall), alcohol use (winter), and financial literacy (spring). The control group will receive the materials via e-mail for participants to review on their own time. A research assistant will meet with control participants via Zoom to explain the materials. The Zoom session will take approximately 1 hour.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

Technology-assisted diabetes prevention programs (DPP), including mobile text messaging, apps, and telehealth, have shown potential for clinically meaningful weight loss and cost-effectiveness in preventing type 2 diabetes.

These interventions can be widely distributed and sustained, making them accessible options for individuals at risk for diabetes, although further research is needed to identify the most effective combination of features for these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Technology-Assisted Interventions for Diabetes Prevention. Grock, S., Ku, JH., Kim, J., et al.[2022]

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]

A study analyzing FDA Adverse Event Reporting System data from January 2013 to March 2022 found that different DPP-4 inhibitors have varying risks for serious side effects, such as acute kidney injury and pemphigoid, which can guide treatment choices for diabetes patients.

Specifically, alogliptin showed a significantly lower risk of acute kidney injury compared to sitagliptin, but a higher risk of pemphigoid, highlighting the importance of selecting the appropriate DPP-4 inhibitor based on a patient's specific health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. Ogura, T., Shiraishi, C.[2023]

Incretin-based therapies, including DPP-4 inhibitors and GLP-1 receptor agonists, provide effective glycemic control in type 2 diabetes with lower rates of hypoglycemia compared to other diabetes medications, based on a review of 112 clinical trials lasting at least 26 weeks.

The most common side effects were infections for DPP-4 inhibitors and gastrointestinal issues for GLP-1 receptor agonists, but serious concerns like pancreatitis and thyroid tumors were rare, indicating a favorable safety profile, though long-term safety monitoring is still necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of incretin-based therapies in type 2 diabetes. Evans, M., Bain, SC., Vora, J.[2019]

A systematic review of 11 trials found that lower-intensity lifestyle interventions for prediabetes showed limited effectiveness, with only one high-quality study demonstrating a 3-kg weight reduction and a 0.2% decrease in HbA1c over 6 months.

The overall evidence for these lower-intensity interventions is weak, highlighting the need for more robust research to explore their potential in diabetes prevention, especially given the low participation in traditional, high-intensity programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-Intensity Interventions for Prediabetes: A Systematic Review. Tseng, E., Lam, KY., Meza, KA., et al.[2023]

Dipeptidyl peptidase (DPP)-4 inhibitors have been shown to neither increase nor decrease the risk of major cardiovascular events in high-risk patients, based on several completed cardiovascular safety trials.

The differences in outcomes between cardiovascular safety trials and earlier studies with metabolic endpoints may be attributed to the distinct patient populations and trial designs, highlighting the need for careful consideration of these factors when assessing drug efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analyses of Results From Cardiovascular Safety Trials With DPP-4 Inhibitors: Cardiovascular Outcomes, Predefined Safety Outcomes, and Pooled Analysis and Meta-analysis. Mannucci, E., Mosenzon, O., Avogaro, A.[2019]

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]

Citations

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This novel study is the first to tailor the DPP to address SD cultural and socioeconomic barriers that limit DPP attendance and reduce its effectiveness on ...

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The primary aim of the project is to assess the effect of Power-Up versus NDPP on weight loss among men with prediabetes. The secondary aim is ...

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After 12 months, the study team found 31.7% of AI-DPP participants and 31.9% of human-led DPP participants met the CDC-defined composite ...

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Diabetes prevention programs (DPPs) have demonstrated efficacy in stopping or delaying the progression of prediabetes to T2D [10]. These interventions reduce ...

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Tailored DPP Intervention for Prediabetes

The Diabetes Prevention Program (DPP) effectively identified high-risk adults for type 2 diabetes, with 27% of participants showing impaired glucose tolerance ...

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The findings from the DPP trial, published in 2002, indicated a 58% reduction in the risk of developing type 2 diabetes among adults with ...