Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial

Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality globally. Strong evidence supports the importance of diet and other lifestyle factors in preventing T2DM. Among individuals with T2DM, low-carbohydrate diets lead to decreases in hemoglobin A1c (HbA1c). However, research on...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2021-02, Vol.22 (1), p.108-108, Article 108
Main Authors: Dorans, Kirsten S, Bazzano, Lydia A, Qi, Lu, He, Hua, Appel, Lawrence J, Samet, Jonathan M, Chen, Jing, Mills, Katherine T, Nguyen, Bernadette T, O'Brien, Matthew J, Uwaifo, Gabriel I, He, Jiang
Format: Article
Language:English
Subjects:
Behavioral dietary intervention
Blood & organ donations
Carbohydrates
Care and treatment
Clinical trials
Coronaviruses
COVID-19
Diabetes
Diabetic neuropathy
Diet
Epidemiology
Glucose
Health care
Hemoglobin
Intervention
Low-carbohydrate diet
Nuts
Prediabetes
Prediabetic state
Prevention
Preventive medicine
Public health
Skin cancer
Study Protocol
Testing
Type 2 diabetes
Weight control
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Summary:Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality globally. Strong evidence supports the importance of diet and other lifestyle factors in preventing T2DM. Among individuals with T2DM, low-carbohydrate diets lead to decreases in hemoglobin A1c (HbA1c). However, research on the effects of low-carbohydrate diets on glycemic outcomes among individuals not currently on glucose-lowering medications who have elevated HbA1c is limited. The objective of this randomized controlled trial is to study the effect of a healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation compared with usual diet on HbA1c and other metabolic risk factors among individuals with HbA1c from 6.0 to 6.9% who are not on glucose-lowering medications. In this parallel trial, 150 participants will be randomized to the intervention or control group for 6 months. The healthy low-carbohydrate diet target is
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-020-05001-x