RecruitingNot ApplicableNCT04943926

Dietary Strategies for Remission of Type 2 Diabetes

Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)


Sponsor

University of Bergen

Enrollment

600 participants

Start Date

Jan 4, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 24 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

Interventions

OTHEREnergy restricted diet

Nutritional complete formula diet followed by an energy restricted diet

OTHERLow carbohydrate high fat diet

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


Locations(1)

Department of Clinical Science

Bergen, Vestland, Norway

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NCT04943926


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