At a glance
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Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
In Brief
A clinical study evaluating Low-Carbohydrate Diet for Diabetes and 7 related conditions. Completed, enrolled 150 participants across 1 site.
Detailed Summary
The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.
Study Details
Timeline
Interventions
Behavioral modification to reduce carbohydrate consumption. Target \<40 g net carbohydrates per day for first 3 months; \<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations.