Dietary Strategies for Remission of Type 2 Diabetes

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.

NCT Number	NCT04943926
Lead Sponsor	University of Bergen Collaborators: Karolinska Institutet, University of Glasgow, University of Copenhagen, Technical University of Munich
Conditions	Diabetes Mellitus, Type 2, Overweight and Obesity, Hypertension, Glucose Intolerance, Insulin Resistance, Dyslipidemia Associated With Type II Diabetes Mellitus
Enrollment	600 participants
Start Date	2022-01-04
Primary Completion	2024-12-31 (estimated)
Study Completion	2040-12-31 (estimated)
Updated on ClinicalTrials.gov	2022-07-08