Dietary Strategies for Remission of Type 2 Diabetes

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

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

Conditions7

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