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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.
Saslow, Laura R; Eslamian, Adriana; Moran, Patricia; Hartogensis, Wendy; Mason, Ashley E; Kim, Sarah; Bauer, Douglas C; Griauzde, Dina Hafez; Goldman, Veronica; Liu, Vivian; Stephens, Pam; Raymond, Kate; Yeung, George; Leung, Cindy; Hecht, Frederick M.
Afiliación
  • Saslow LR; University of Michigan, Ann Arbor, MI, USA. saslowl@umich.edu.
  • Eslamian A; University of California, San Francisco, CA, USA.
  • Moran P; University of California, San Francisco, CA, USA.
  • Hartogensis W; University of California, San Francisco, CA, USA.
  • Mason AE; University of California, San Francisco, CA, USA.
  • Kim S; University of California, San Francisco, CA, USA.
  • Bauer DC; University of California, San Francisco, CA, USA.
  • Griauzde DH; University of Michigan, Ann Arbor, MI, USA.
  • Goldman V; University of California, San Francisco, CA, USA.
  • Liu V; University of California, San Francisco, CA, USA.
  • Stephens P; University of Michigan, Ann Arbor, MI, USA.
  • Raymond K; University of Michigan, Ann Arbor, MI, USA.
  • Yeung G; University of California, San Francisco, CA, USA.
  • Leung C; Harvard University, Cambridge, MA, USA.
  • Hecht FM; University of California, San Francisco, CA, USA.
Trials ; 24(1): 463, 2023 Jul 20.
Article en En | MEDLINE | ID: mdl-37475033
BACKGROUND: Optimal 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. METHODS: The 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 REGISTRATION: ClinicalTrials.gov NCT05237128. Registered on February 11, 2022.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Clinical_trials / Guideline Límite: Adult / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Clinical_trials / Guideline Límite: Adult / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido