NCT05237128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

3.5 years

First QC Date

February 2, 2022

Last Update Submit

November 5, 2025

Conditions

Type 2 Diabetes

Keywords

Very low-carbohydrate dietModerate-carbohydrate plate-method dietNutrition therapy

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

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

    0 to 12 months

Secondary Outcomes (13)

  • Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)

    0 to 12 months

  • Change in small particle low-density lipoproteins (LDL)

    0 to 12 months

  • Change in high-density lipoproteins (HDL)

    0 to 12 months

  • Change in triglycerides

    0 to 12 months

  • Change in percent body weight loss

    0 to 12 months

  • +8 more secondary outcomes

Study Arms (2)

Very low-carbohydrate diet

EXPERIMENTAL
Behavioral: Very low-carbohydrate diet

Moderate-carbohydrate plate-method diet

EXPERIMENTAL
Behavioral: Moderate-carbohydrate plate-method diet

Interventions

Very low-carbohydrate dietBEHAVIORAL

Participants in this arm will be taught to manage their type 2 diabetes using a very low-carbohydrate diet, also called a ketogenic or "keto" diet. This diet involves eating non-starchy vegetables, leafy greens, cheese, meats, berries, nuts, and seeds and avoiding starchy foods like pasta, bread, rice, beans, many fruits, etc. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Very low-carbohydrate diet
Moderate-carbohydrate plate-method dietBEHAVIORAL

Participants in this arm will be taught to manage their type 2 diabetes using a plate-method approach. This diet involves eating different categories of foods based on the proportions of a plate, balancing proteins, vegetables, fruits, starches, and fats. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Moderate-carbohydrate plate-method diet

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

University of MIchigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Saslow LR, Eslamian A, Moran P, Hartogensis W, Mason AE, Kim S, Bauer DC, Griauzde DH, Goldman V, Liu V, Stephens P, Raymond K, Yeung G, Leung C, Hecht FM. Protocol for a randomized controlled trial comparing a very low-carbohydrate diet or moderate-carbohydrate plate-method diet for type 2 diabetes: the LEGEND (Lifestyle Education about Nutrition for Diabetes) trial. Trials. 2023 Jul 20;24(1):463. doi: 10.1186/s13063-023-07512-9.

    PMID: 37475033DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Laura Saslow, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment and data analysis will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 11, 2022

Study Start

March 22, 2022

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)