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

University of Michigan2 sites in 1 country182 target enrollmentMarch 22, 2022

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: University of Michigan
Enrollment: 182
Locations: 2
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

March 22, 2022

End Date

October 1, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Laura Saslow

Assistant Professor

University of Michigan

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: 0 to 12 months

HbA1c will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Secondary Outcomes

Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)(0 to 12 months)
Change in high-density lipoproteins (HDL)(0 to 12 months)
Change in percent lean body mass on DEXA(0 to 12 months)
Change in HbA1c(0 to 4 months)
Change in bone mineral density in total hip(0 to 12 months)
Change in small particle low-density lipoproteins (LDL)(0 to 12 months)
Change in triglycerides(0 to 12 months)
Change in percent body fat on DEXA(0 to 12 months)
Change in bone mineral density in lumbar spine(0 to 12 months)
Reduction in diabetes medications using medication effect score (MES)(0 to 12 months)
Change in percent body weight loss(0 to 12 months)
Change in serum procollagen type I N propeptide (s-PINP)(0 to 12 months)
Change in serum c-terminal telopeptide of type 1 collagen (s-CTX)(0 to 12 months)