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

Plain Language Summary

Simplified for easier understanding

This study tests whether specific dietary approaches (such as very low-calorie diets or low-carbohydrate diets) can cause type 2 diabetes to go into remission — meaning blood sugar levels return to normal without needing medication. **You may be eligible if...** - You have type 2 diabetes (HbA1c ≥48 mmol/mol, which is approximately 6.5% or above) - You were diagnosed with type 2 diabetes less than 10 years ago - Your BMI is 27 or higher (or 25 or higher if you are of Asian descent) **You may NOT be eligible if...** - You are on more than 25 units of insulin per day - Your HbA1c is extremely high (12% or above) - You have had a heart attack in the last 6 months - You have severe heart failure, active cancer, a psychiatric or eating disorder, or severe depression - Lab tests suggest your body is producing very little insulin on its own Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04943926


Related Trials