NCT04943926 Dietary Strategies for Remission of Type 2 Diabetes
| NCT ID | NCT04943926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bergen |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-01-04 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2022-01-04 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04943926 clinical trial?
This trial is open to participants of all sexes, aged 24 Years or older, up to 70 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04943926 currently recruiting?
Yes, NCT04943926 is actively recruiting participants. Contact the research team at Simon.Dankel@uib.no for enrollment information.
Where is the NCT04943926 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT04943926 clinical trial?
NCT04943926 is sponsored by University of Bergen. The trial plans to enroll 600 participants.
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