Dietary Strategies for Remission of Type 2 Diabetes

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.

Conditions

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

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)

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• University of Bergen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

24 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-04

Primary Completion

2024-12-31

Completion

2040-12-31

Countries

• Norway

Study Locations