Dietary Strategies for Remission of Type 2 Diabetes

Recruiting · NCT04943926 · Interventional (participants receive a specific treatment)

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Interventions studied

Energy restricted dietLow carbohydrate high fat diet

What this trial is about

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.

Who can take part

Age range

24 Years to 70 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 it is running

1 location listed.

Department of Clinical Science - Bergen, Vestland, Norway

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →