No phaseCompleted

The Lifestyle Education About Prediabetes (Leap) Study (LEAP)

Testing a Very Low-carbohydrate Diet Version of the Diabetes Prevention Program to Reduce Risk Factors for Type 2 Diabetes: The LEAP (Lifestyle Education About Prediabetes) Study

Sponsor
University of Michigan (Academic or other)
Enrolment
304 enrolled
Conditions
PreDiabetes
Interventions
Standard NDPP; Very low-carbohydrate diet
Ages
adults, older adults
Registry
NCT05235425

From the registry

This research tested whether a standard version or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes. Participants had screening (included blood draw) and baseline testing with a continuous glucose monitor. Once these enrollment steps were completed, the participants were randomized to one of two groups: a standard National Diabetes Prevention Program (NDPP) or a very low-carbohydrate version. In addition to following the diet for 12 months, participants were asked to participate in hour-long weekly group classes over Zoom. After four months in the program, classes occurred about every month to help participants maintain the new diet. There were also check-ins and follow-up visits throughout the study.

Primary outcomes

  • Change in HbA1c
Full record on ClinicalTrials.gov