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Search / Trial NCT04943926

Dietary Strategies for Remission of Type 2 Diabetes

Launched by UNIVERSITY OF BERGEN · Jun 21, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Low Carbohydrate High Fat Diet Energy Restricted Diet Lifestyle Change Ketogenic Diet Total Meal Replacement

ClinConnect Summary

This clinical trial is investigating two different dietary approaches to see which one can help people with type 2 diabetes (T2D) achieve and maintain remission. The first method encourages a moderate, whole food-based low-carbohydrate, high-fat diet that allows participants to eat until they feel satisfied, while the second method involves a very low-calorie formula diet followed by a calorie-restricted eating plan. The goal is to find out if these diets can lead to similar success in managing diabetes and whether certain factors, like changes in blood sugar levels or body measurements, can predict how well someone will respond to the diet.

To be eligible for the study, participants should have been diagnosed with T2D within the last 10 years and have an HbA1c level of at least 48 mmol/mol, which is a measure of average blood sugar. They should also have a body mass index (BMI) of 27 or higher (or 25 for Asian participants). Throughout the trial, participants will receive personalized dietary advice and will be monitored for changes in their health, including medication use and any side effects. This trial is currently looking for volunteers of all genders, aged between 18 and 75.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • HbA1c ≥48 mmol/mol (with or without medical treatment)
  • Less than 10 years since the diagnosis of T2D
  • BMI ≥27 kg/m2 (≥25 kg/m2 for Asians)
  • Exclusion Criteria:
  • Treatment with insulin \>25 IU
  • HbA1c concentration of 12% or more (≥108 mmol/mol)
  • Insulin to C-peptide ratio \<0.8 (indicative of insulin deficiency)
  • Myocardial infarction within the previous 6 months, and severe or unstable heart failure or other severe diseases including cancer, psychiatric/eating disorders, severe depression and substance abuse

About University Of Bergen

The University of Bergen is a renowned academic institution located in Norway, recognized for its commitment to advancing medical research and education. With a focus on interdisciplinary collaboration, the university engages in innovative clinical trials that aim to improve patient outcomes and enhance healthcare practices. Leveraging its diverse expertise and state-of-the-art facilities, the University of Bergen fosters a dynamic research environment that attracts both national and international partners, ensuring the translation of scientific discoveries into effective clinical applications. The institution is dedicated to maintaining the highest ethical standards and regulatory compliance in all its research endeavors.

Locations

Bergen, Vestland, Norway

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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