Clinical trial

Dietary Strategies for Remission of Type 2 Diabetes

Recruiting now · Not applicable · 1 countries · Registry ID NCT04943926

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age24 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus, Type 2, Overweight and Obesity, Hypertension, Glucose Intolerance, Insulin Resistance, Dyslipidemia Associated With Type II Diabetes Mellitus

Full registry 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

Treatments and study arms

Energy restricted diet

Other

Nutritional complete formula diet followed by an energy restricted diet

Low carbohydrate high fat diet

Other

Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)

Primary outcomes

Diabetes remission15 months

Number of patients with diabetes remission, defined as no use of glucose-lowering drugs and HbA1c \<48 mmol/mol (\<6.5%) at 15 months

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Clinical Science🇳🇴 Bergen, Vestland, Norway

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Pål R NjølstadContact

Email · Call +47 55 97 51 53