Clinical trial NCT05237128: The Lifestyle Education About Nutrition for Diabetes (Legend) Study
Official title: Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Very low-carbohydrate diet
Moderate-carbohydrate plate-method diet
Nutrition therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-02-11
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 0 to 12 months
Secondary outcomes:
measure: Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)
timeFrame: 0 to 12 months
measure: Change in small particle low-density lipoproteins (LDL)
timeFrame: 0 to 12 months
measure: Change in high-density lipoproteins (HDL)
timeFrame: 0 to 12 months
measure: Change in triglycerides
timeFrame: 0 to 12 months
measure: Change in percent body weight loss
timeFrame: 0 to 12 months
measure: Change in percent body fat on DEXA
timeFrame: 0 to 12 months
measure: Change in percent lean body mass on DEXA
timeFrame: 0 to 12 months
measure: Change in bone mineral density in total hip
timeFrame: 0 to 12 months
measure: Change in bone mineral density in lumbar spine
timeFrame: 0 to 12 months
measure: Change in serum procollagen type I N propeptide (s-PINP)
timeFrame: 0 to 12 months
measure: Change in serum c-terminal telopeptide of type 1 collagen (s-CTX)
timeFrame: 0 to 12 months
measure: Reduction in diabetes medications using medication effect score (MES)
timeFrame: 0 to 12 months
measure: Change in HbA1c
timeFrame: 0 to 4 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: The University of California San Francisco (UCSF)
state: California
city: Ann Arbor
country: United States
facility: University of MIchigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Laura Saslow, PhD
role: PRINCIPAL_INVESTIGATOR
References: