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Diet Modification for Type 2 Diabetes (LEGEND Trial)

N/A
Recruiting
Led By Laura Saslow, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness to be randomized to either type of diet
Diagnosis of type 2 diabetes, with current HbA1c > 6.5% and < 12% (self-reported and then measured at screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 4 months
Awards & highlights

LEGEND Trial Summary

This trial is testing 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.

Who is the study for?
This trial is for English-speaking adults with type 2 diabetes, who have an HbA1c level between 6.5% and <12%, can do light exercise, and are willing to follow a new diet plan for a year. Pregnant women, those over 400 pounds, or on certain diets or medications are excluded.Check my eligibility
What is being tested?
The study compares two diets: a moderate-carbohydrate plate-method diet versus a very low-carbohydrate diet to see which one better improves blood sugar control and body weight in type 2 diabetes patients over the course of one year.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include changes in blood sugar levels that could require medication adjustments, digestive changes due to dietary shifts, and possible nutrient deficiencies if not properly managed.

LEGEND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to follow any diet assigned to me in the study.
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I have type 2 diabetes with an HbA1c level between 6.5% and 12%.
Select...
I have type 2 diabetes with an HbA1c level between 6.5% and 12%.
Select...
I can do light physical activities.

LEGEND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in HbA1c
Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)
Change in bone mineral density in lumbar spine
+10 more

LEGEND Trial Design

2Treatment groups
Experimental Treatment
Group I: Very low-carbohydrate dietExperimental Treatment1 Intervention
Group II: Moderate-carbohydrate plate-method dietExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,364,942 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,228 Total Patients Enrolled
Laura Saslow, PhDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
528 Total Patients Enrolled

Media Library

Moderate-carbohydrate plate-method diet Clinical Trial Eligibility Overview. Trial Name: NCT05237128 — N/A
Type 2 Diabetes Research Study Groups: Very low-carbohydrate diet, Moderate-carbohydrate plate-method diet
Type 2 Diabetes Clinical Trial 2023: Moderate-carbohydrate plate-method diet Highlights & Side Effects. Trial Name: NCT05237128 — N/A
Moderate-carbohydrate plate-method diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05237128 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings still available for this trial?

"Data on clinicaltrials.gov reveals that this medical trial is actively searching for participants and has been updated as recently as July 3rd, 2022 since its original posting date of March 22nd, 2022."

Answered by AI

How many participants are currently receiving treatment in this experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this research study is presently recruiting participants; it was originally posted on March 22nd 2022 and updated July 3rd 2022. 180 individuals are needed from two different facilities for full enrollment into this trial."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
The University of California San Francisco (UCSF)
What portion of applicants met pre-screening criteria?
Met criteria
~72 spots leftby Jul 2025