Comparing Two Diet Approaches to Achieve Remission of Type 2 Diabetes A Randomized Trial of Low-Carb High-Fat Versus Energy-Restricted Formula Diet

What this Trial Is About

Researchers are conducting a multicenter randomized controlled trial to compare two dietary strategies for achieving remission of type 2 diabetes T2D. The study evaluates whether a moderate, whole food-based low-carbohydrate high-fat LCHF diet can produce similar remission rates as a nutritionally complete very-low-calorie formula diet followed by an energy-restricted diet based on DiRECT principles. The study also investigates whether changes in glucose variability, body measurements, and genetic factors can predict remission, alongside other mechanistic research on fat accumulation and metabolism. Participants will be randomized into two groups one will follow a complete formula diet for 3 months followed by a 12-month energy-restricted diet, while the other will follow a very low-carbohydrate high-fat ketogenic diet for 3 months followed by a low-carbohydrate high-fat diet for 12 months. Both diets meet essential nutrient needs and emphasize high-quality, minimally processed foods, with specific fat sources recommended in the LCHF arm. Participants have access to online resources, e-learning courses, and support from health educators and dietitians, with rescue plans if weight gain or diabetes relapse occurs. During the study, participants will visit the center at baseline, 3, 9, and 15 months to undergo assessments including continuous glucose monitoring, food intake recording, body composition, energy expenditure, and biological sample collection. Questionnaires on lifestyle and quality of life will be completed, and medical consultations provided. The primary outcome is diabetes remission at 15 months, with additional measures including medication changes, blood sugar levels, insulin function, eating behavior, and quality of life monitored throughout. A blinded statistician will analyze the results.

Dietary Strategies for Remission of Type 2 Diabetes