NCT05237128Completed
The Lifestyle Education About Nutrition for Diabetes (Legend) Study
Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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 outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months. Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 182 (actual)
- First submitted
- 2 Feb 2022
- Start date
- Mar 2022
- Primary completion date
- Oct 2025
- Lead sponsor
- University of Michigan
- Diseases
- Type 2 diabetes
- NCT number
- NCT05237128
What you commit to
- Study type: Interventional
- Participants enrolled: 182
- From Mar 2022 to the primary completion date, Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current use of weight loss medications (this is likely to alter weight outcomes and may alter other measures)
- 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))
- unwilling to stop an SGLT2 inhibitor medication if the participant were to be randomized to the very low-carbohydrate diet
Other illness
- 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
- history of weight loss (bariatric) surgery or plans for bariatric surgery in the next year
- history of multiple or recent (within the last four years) kidney stones
Other
- unable to provide informed consent
- 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)
- 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
- weight above 400 pounds (weight limit for dual-energy X-ray absorptiometry (DEXA) scans)
- currently following a very low-carbohydrate diet
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| The University of California San Francisco (UCSF) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.