Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dietary Strategies for Remission of Type 2 Diabetes
Sponsor: University of Bergen
Summary
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.
Official title: Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)
Key Details
Gender
All
Age Range
24 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2022-01-04
Completion Date
2040-12-31
Last Updated
2022-07-08
Healthy Volunteers
No
Conditions
Interventions
Energy restricted diet
Nutritional complete formula diet followed by an energy restricted diet
Low carbohydrate high fat diet
Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)
Locations (1)
Department of Clinical Science
Bergen, Vestland, Norway