Dietary strategies to achieve remission of Type 2 Diabetes
Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)
This study is testing whether a low-carb, whole food diet works better than a very low-calorie diet for helping people with Type 2 Diabetes achieve remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 24 Years to 70 Years |
| Sex | All |
| Sponsor | University of Bergen Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT04943926 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to compare the effectiveness of a moderate, whole food-based low-carbohydrate high-fat diet against a nutritionally complete very-low-calorie formula diet followed by an energy-restricted diet in achieving remission of Type 2 Diabetes. The study will recruit at least 588 participants, who will be randomized into two dietary intervention groups, with adjustments made based on individual needs to promote long-term adherence. Researchers will also investigate whether changes in glucose variability and other factors can predict diet-induced remission rates. Each dietary approach will ensure participants receive essential nutrients while emphasizing high-quality, minimally processed foods.
Who should consider this trial
Good fit: Ideal candidates include adults with a diagnosis of Type 2 Diabetes for less than 10 years, a BMI of 27 kg/m2 or higher, and an HbA1c level of 48 mmol/mol or higher.
Not a fit: Patients who are insulin-dependent or have severe comorbid conditions such as recent myocardial infarction or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies for achieving remission of Type 2 Diabetes, potentially reducing the need for medication.
How similar studies have performed: Previous studies, such as the DiRECT trial, have shown success with similar dietary approaches for Type 2 Diabetes remission.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bergen, Vestland
- Department of Clinical Science — Bergen, Vestland, Norway (Recruiting)
Study contacts
- Study coordinator: Simon N Dankel, PhD
- Email: Simon.Dankel@uib.no
- Phone: +4794308637
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.