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Diabetes Prevention Programs for Prediabetes (LEAP Trial)

N/A
Recruiting
Led By Laura Saslow, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Overweight, defined as BMI >= 25 kg/m2 >= 23 kg/m2 if of Asian descent
Willingness to participate in group-based sessions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-12 months
Awards & highlights

LEAP Trial Summary

This trial will test whether a standard or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes.

Who is the study for?
The Leap Study is for adults with prediabetes, indicated by an HbA1c level between 5.7% and 6.4%. Participants should be overweight, able to do light exercise like walking, have their doctor's approval, and be willing to attend group sessions and adhere to a diet plan. People using certain medications or with specific health conditions are excluded.Check my eligibility
What is being tested?
This study compares two approaches within the Diabetes Prevention Program: a standard method versus a very low-carbohydrate diet in improving blood sugar control and weight loss. Participants will be randomly assigned to one of these diets for a year with support through weekly online classes that later become monthly.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include changes in digestion due to dietary adjustments (like constipation or bloating), possible nutrient deficiencies if the diet isn't well-balanced, and initial symptoms of carbohydrate withdrawal such as fatigue or irritability.

LEAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am overweight according to my BMI.
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I am willing to join group sessions.
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I can do light activities like walking.

LEAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Body Weight Changes
Change in Inflammation based on C-reactive protein (CRP)
Change in glycemic variability
+4 more

LEAP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Very low-carbohydrate diet (VLCD)Experimental Treatment1 Intervention
VLCD is an adaptation of the standard NDPP curriculum, which preserves all features with the exception of altered dietary advice.
Group II: Standard NDPPActive Control1 Intervention
12-month long, calorie-restricted NDPP

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,222 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,108 Total Patients Enrolled
Laura Saslow, PhDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
408 Total Patients Enrolled

Media Library

Standard NDPP Clinical Trial Eligibility Overview. Trial Name: NCT05235425 — N/A
Prediabetes Research Study Groups: Standard NDPP, Very low-carbohydrate diet (VLCD)
Prediabetes Clinical Trial 2023: Standard NDPP Highlights & Side Effects. Trial Name: NCT05235425 — N/A
Standard NDPP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05235425 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria that would exclude me from partaking in this research?

"Interested individuals between the ages of 21 and 75 with pre-diabetic conditions are encouraged to apply for this research trial, which is currently enrolling approximately 300 participants."

Answered by AI

Is this clinical trial currently open to new enrollees?

"According to clinicaltrials.gov, this medical experiment is actively searching for participants. The trial was initially advertised on March 20th 2022 and the details were most recently updated on July 3rd 2022."

Answered by AI

How many people are taking part in this research project?

"Affirmative. Records on clinicaltrials.gov reveal that this research project, initially posted in March 2022 and most recently revised in July of the same year, is urgently seeking 300 volunteers from a single site."

Answered by AI

Does this medical trial have any age restrictions?

"This medical trial is seeking out individuals between the ages of 21 and 75. In contrast, there are 15 trials for patients below 18 and 184 clinical studies that cater to adults over 65 years old."

Answered by AI
~115 spots leftby Jul 2025