Evidence map›Paper›PMID 37475033›Full record

ArticleTrials2023

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.

Laura R Saslow, Adriana Eslamian, Patricia Moran, Wendy Hartogensis, Ashley E Mason, Sarah Kim, Douglas C Bauer, Dina Hafez Griauzde, Veronica Goldman, Vivian Liu and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05237128 (Comparing Two Dietary Approaches for Type 2 Diabetes), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 84% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05237128 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of MichiganRan2022 to 2025Enrolled182ConditionsType 2 DiabetesArmsVery low-carbohydrate diet, Moderate-carbohydrate plate-method diet
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

Laura R SaslowUniversity of Michigan, Ann Arbor, MI, USA. saslowl@umich.edu.ORCID http://orcid.org/0000-0003-3991-3205
Adriana EslamianUniversity of California, San Francisco, CA, USA.
Patricia MoranUniversity of California, San Francisco, CA, USA.
Wendy HartogensisUniversity of California, San Francisco, CA, USA.
Ashley E MasonUniversity of California, San Francisco, CA, USA.
Sarah KimUniversity of California, San Francisco, CA, USA.
Douglas C BauerUniversity of California, San Francisco, CA, USA.
Dina Hafez GriauzdeUniversity of Michigan, Ann Arbor, MI, USA.
Veronica GoldmanUniversity of California, San Francisco, CA, USA.
Vivian LiuUniversity of California, San Francisco, CA, USA.
Pam StephensUniversity of Michigan, Ann Arbor, MI, USA.
Kate RaymondUniversity of Michigan, Ann Arbor, MI, USA.
George YeungUniversity of California, San Francisco, CA, USA.
Cindy LeungHarvard University, Cambridge, MA, USA.
Frederick M HechtUniversity of California, San Francisco, CA, USA.
University of California, San Francisco · USUniversity of Michigan · USHarvard University Press · US

Funding

Pilot and Feasibility (P and F) ProgramP30DK089503 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Jeffrey F Horowitz · 2010 to 2026
$20.3M
UCSF Nutrition Obesity Research CenterP30DK098722 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHRISTIAN VAISSE · 2015 to 2026
$14.6M
Research BaseP30DK092926 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MARY ELLEN MICHELE HEISLER, ADESUWA B OLOMU · 2011 to 2026
$10.0M
Comparing Two Dietary Approaches for Type 2 DiabetesR01DK126898 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SASLOW, LAURA · 2021 to 2025
$3.4M
A multilevel intervention to support weight loss among individuals with prediabetes in primary care settingsK23DK123416 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI GRIAUZDE, DINA HAFEZ · 2020 to 2024
$962k
NIDDK NIH HHS K23 DK123416NIDDK NIH HHS P30 DK089503NIDDK NIH HHS P30 DK092926NIDDK NIH HHS P30 DK098722NIDDK NIH HHS R01 DK126898NIDDK NIH HHS R01DK126898
6 · The paper itself

Abstract

backgroundOptimal carbohydrate intake is an important and controversial area in the nutritional management of type 2 diabetes. Some evidence indicates that reducing overall carbohydrate intake with a low- or very low-carbohydrate eating plan can improve glycemic control compared to following eating plans that involve greater carbohydrate intake. However, critical knowledge gaps currently prevent clear recommendations about carbohydrate intake levels.

methodsThe LEGEND (Lifestyle Education about Nutrition for Diabetes) Trial aims to compare a very low-carbohydrate diet to a moderate-carbohydrate plate-method diet for glycemic control in adults with type 2 diabetes. This two-site trial plans to recruit 180 adults with type 2 diabetes. We will randomize participants to either a 20-session group-based diet and lifestyle intervention that teaches either a very low-carbohydrate diet or a moderate-carbohydrate plate-method diet. We will assess participants at study entry and 4 and 12 months later. The primary outcome is HbA1c, and secondary outcomes include inflammation (high sensitivity C-reactive protein), body weight, changes in diabetes medications, lipids (small particle LDL, HDL, triglycerides), skeletal metabolism (bone mineral density from dual-energy x-ray absorptiometry and bone turnover markers serum procollagen type I N propeptide and serum C-terminal telopeptide of type I collagen), and body composition (percent body fat, percent lean body mass). DISCUSSION: The LEGEND trial is a randomized controlled trial to assess optimal carbohydrate intake in type 2 diabetes by evaluating the effects of a very low-carbohydrate diet vs. a moderate-carbohydrate plate-method diet over a year-long period. The research addresses important gaps in the evidence base for the nutritional management of type 2 diabetes by providing data on potential benefits and adverse effects of different levels of carbohydrate intake.

trial registrationClinicalTrials.gov NCT05237128. Registered on February 11, 2022.

Indexed as

Diabetes Mellitus, Type 2AdultBlood GlucoseCarbohydratesCollagen Type IDiet, Carbohydrate-RestrictedHumansLife StyleRandomized Controlled Trials as TopicBlood GlucoseCarbohydratesCollagen Type IProcollagen Type IGlycemic controlLifestyle interventionRandomized controlled trialType 2 diabetes

Identifiers

PMID37475033
PMCPMC10360267
OpenAlexW4384925841

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.