No phaseActive, not recruiting
Dietary Strategies for Remission of Type 2 Diabetes (CARBCOUNT)
Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)
- Sponsor
- University of Bergen (Academic or other)
- Enrolment
- 600 planned
- Conditions
- Diabetes Mellitus, Type 2; Overweight and Obesity; Hypertension; Glucose Intolerance; Insulin Resistance; Dyslipidemia Associated With Type II Diabetes Mellitus
- Interventions
- Energy restricted diet; Low carbohydrate high fat diet
- Ages
- adults, older adults
- Registry
- NCT04943926
From the registry
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…
Primary outcomes
- Diabetes remission