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RECRUITING
NCT04943926
NA

Dietary Strategies for Remission of Type 2 Diabetes

Sponsor: University of Bergen

View on ClinicalTrials.gov

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

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)

Locations (1)

Department of Clinical Science

Bergen, Vestland, Norway