The Lifestyle Education About Nutrition for Diabetes (Legend) Study

a study on Diabetes Diabetes Type 2

Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Rick Hecht, MD (ucsf)
Headshot of Rick Hecht
Rick Hecht

Description

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 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.

Official Title

Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study

Keywords

Type 2 Diabetes, Very low-carbohydrate diet, Moderate-carbohydrate plate-method diet, Nutrition therapy, Diabetes Mellitus, Type 2 Diabetes Mellitus

Eligibility

You can join if…

Open to people ages 21 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • The University of California San Francisco (UCSF) accepting new patients
    San Francisco California 94143 United States
  • University of MIchigan accepting new patients
    Ann Arbor Michigan 48109 United States

Lead Scientist at University of California Health

  • Rick Hecht, MD (ucsf)
    I am trained in Internal Medicine, with additional training in clinical research methods, biostatistics, and behavioral medicine. My research focus for many years was on HIV.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT05237128
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated