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Diabetes Prevention Programs for Prediabetes (LEAP Trial)

N/A
Waitlist Available
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
Be older than 18 years old
Must not have
Inability to read, write, or speak English
Difficulty chewing or swallowing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two diet programs to see which one better helps people with prediabetes control their blood sugar and lose weight. One program follows a regular diet, while the other focuses on eating very few carbohydrates. Participants will also attend group classes for support and education.

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot read, write, or speak English.
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I have trouble chewing or swallowing.
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I am taking diabetes medication that is not metformin.
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I am taking warfarin.
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I have not been treated for an eating disorder or severe mental health issues like depression with thoughts of suicide, bipolar disorder, or schizophrenia.
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I am not using any anti-obesity drugs or participating in another weight loss program.
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I have a blood condition that affects my HbA1c levels.
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I am taking a water pill (diuretic) equivalent to 20mg or more of furosemide.
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I have a history of diabetes (type 1 or type 2).
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I have had or plan to have weight loss surgery during the study.
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My kidney function is severely reduced.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Body Weight Changes
Change in Inflammation based on C-reactive protein (CRP)
Change in glycemic variability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prediabetes include lifestyle modifications such as dietary changes and increased physical activity. A very low-carbohydrate diet, which is being studied in trials, works by significantly reducing carbohydrate intake, leading to lower blood glucose levels and promoting weight loss. This diet helps to decrease insulin resistance and improve glycemic control by minimizing the glucose spikes that typically follow carbohydrate consumption. For prediabetes patients, these mechanisms are crucial as they can prevent the progression to type 2 diabetes and reduce the risk of associated complications.
The DAPA-DIET study: Metabolic response to Dapagliflozin combined with dietary carbohydrate restriction in patients with Type 2 Diabetes Mellitus and Obesity-A longitudinal cohort study.Do Cinnamon Supplements Have a Role in Glycemic Control in Type 2 Diabetes? A Narrative Review.Revisiting weight reduction and management in the diabetic patient: Novel therapies provide new strategies.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,860 Previous Clinical Trials
6,437,620 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,334,808 Total Patients Enrolled
Laura Saslow, PhDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
438 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
~46 spots leftby Jul 2025