Actively Recruiting

Phase Not Applicable
Age: 24Years - 70Years
All Genders
NCT04943926

Dietary Strategies for Remission of Type 2 Diabetes

Led by University of Bergen · Updated on 2022-07-08

600

Participants Needed

1

Research Sites

990 weeks

Total Duration

On this page

Sponsors

U

University of Bergen

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Dietary Strategies for Remission of Type 2 Diabetes

Who Can Participate

Age: 24Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HbA1c 48 mmol/mol or higher (with or without medical treatment)
  • Diagnosis of type 2 diabetes less than 10 years ago
  • Body mass index (BMI) 27 kg/m2 or higher (25 kg/m2 or higher for Asians)
Not Eligible

You will not qualify if you...

  • Insulin treatment over 25 IU
  • HbA1c concentration of 12% or more (108 mmol/mol or higher)
  • Insulin to C-peptide ratio less than 0.8 indicating insulin deficiency
  • Heart attack within the last 6 months
  • Severe or unstable heart failure
  • Other severe diseases including cancer, psychiatric or eating disorders, severe depression, and substance abuse

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Trial Site Locations

Total: 1 location

1

Department of Clinical Science

Bergen, Vestland, Norway, 5021

Actively Recruiting

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Research Team

S

Simon N Dankel, PhD

CONTACT

K

Kristin Amundsen, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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