Status:
COMPLETED
The Lifestyle Education About Nutrition for Diabetes (Legend) Study
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves ou...
Eligibility Criteria
Inclusion
- diagnosis of type 2 diabetes, with current HbA1c \> 6.5% and \< 12% (self-reported and then measured at screening)
- ability to speak English (this is a group-based intervention)
- ability to engage in light physical activity
- willingness to be randomized to either type of diet
Exclusion
- unable to provide informed consent
- substance abuse, mental health, cognitive, or medical condition that would, in the opinion of the investigators, make it difficult for the individual to take part in the intervention, may alter key outcomes, or may require important diet modifications and includes conditions such as hypercalcemia or thyroid dysfunction
- pregnant or planning to become pregnant in the next 12 months, or currently breastfeeding (pregnancy and breastfeeding require modifications to the intervention's dietary approaches)
- current use of weight loss medications (this is likely to alter weight outcomes and may alter other measures)
- history of weight loss (bariatric) surgery or plans for bariatric surgery in the next year
- currently enrolled in a weight loss program or have unalterable plans to enroll in one of these programs in the next year
- vegan or vegetarian
- unwilling or unable to participate in study measurements and group classes
- current use of systemic steroids (self-reported in screening survey; oral or IV systemic steroids excluded. Injected steroids may be permitted depending on frequency and timing of injections with regard to lab assessments (minimum of 2 weeks between injection and blood tests))
- weight above 400 pounds (weight limit for dual-energy X-ray absorptiometry (DEXA) scans)
- history of multiple or recent (within the last four years) kidney stones
- currently following a very low-carbohydrate diet
- unwilling to stop an SGLT2 inhibitor medication if the participant were to be randomized to the very low-carbohydrate diet
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT05237128
Start Date
March 22 2022
End Date
October 1 2025
Last Update
November 7 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
2
University of MIchigan
Ann Arbor, Michigan, United States, 48109