NCT04943926Active, not recruiting
Dietary Strategies for Remission of Type 2 Diabetes
Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 21 Jun 2021
- Start date
- 4 Jan 2022
- Primary completion date
- 10 Sept 2026
- Lead sponsor
- University of Bergen
- Diseases
- Obesity, High blood pressure, Type 2 diabetes
- NCT number
- NCT04943926
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 4 Jan 2022 to the primary completion date, 10 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with insulin \>25 IU
- 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
Lab values
- HbA1c concentration of 12% or more (≥108 mmol/mol)
Other
- Insulin to C-peptide ratio \<0.8 (indicative of insulin deficiency)
Who the study is looking for
- 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)
Age in the registry: 24 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Science Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.