The Lifestyle Education About Nutrition for Diabetes (Legend) Study (LEGEND)

University of Michigan

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Behavioral: Very low-carbohydrate diet

Behavioral: Moderate-carbohydrate plate-method diet

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05237128

HUM00202808

R01DK126898-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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