Dietary Strategies for Remission of Type 2 Diabetes

Conditions studied

Diabetes Mellitus, Type 2, Overweight and Obesity, Hypertension, Glucose Intolerance, Insulin Resistance, Dyslipidemia Associated With Type II Diabetes Mellitus

About this study

In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs/capabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in/can be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal/hepatic fat accumulation, adipose tissue biopsies and/or measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.

Interventions

• Other: Energy restricted diet — Nutritional complete formula diet followed by an energy restricted diet
• Other: Low carbohydrate high fat diet — Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)

Primary outcomes

• Diabetes remission (15 months)

Eligibility information

Study locations

• Department of Clinical Science, Bergen, Vestland 5021 Norway