Actively Recruiting
Dietary Strategies for Remission of Type 2 Diabetes
Led by University of Bergen · Updated on 2022-07-08
600
Participants Needed
1
Research Sites
990 weeks
Total Duration
On this page
Sponsors
U
University of Bergen
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Dietary Strategies for Remission of Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HbA1c 48 mmol/mol or higher (with or without medical treatment)
- Diagnosis of type 2 diabetes less than 10 years ago
- Body mass index (BMI) 27 kg/m2 or higher (25 kg/m2 or higher for Asians)
You will not qualify if you...
- Insulin treatment over 25 IU
- HbA1c concentration of 12% or more (108 mmol/mol or higher)
- Insulin to C-peptide ratio less than 0.8 indicating insulin deficiency
- Heart attack within the last 6 months
- Severe or unstable heart failure
- Other severe diseases including cancer, psychiatric or eating disorders, severe depression, and substance abuse
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Trial Site Locations
Total: 1 location
1
Department of Clinical Science
Bergen, Vestland, Norway, 5021
Actively Recruiting
Research Team
S
Simon N Dankel, PhD
CONTACT
K
Kristin Amundsen, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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