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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 24
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Norway
Department of Clinical Science
RECRUITING
Bergen
Contact Information
Primary
Simon N Dankel, PhD
Simon.Dankel@uib.no
+4794308637
Backup
Kristin Amundsen, MSc
k.amundsen@uib.no
+4797171257
Time Frame
Start Date: 2022-01-04
Estimated Completion Date: 2040-12-31
Participants
Target number of participants: 600
Treatments
Active_comparator: Energy Restricted Diet
A nutritional complete formula diet for 3 months followed by an energy restricted diet for 12 months.
Experimental: Continuous LCHF Diet
A very low-carbohydrate high-fat ketogenic diet (VLCHF) diet for 3 months, followed by a low-carbohydrate high-fat diet (LCHF) for 12 months.
Sponsors
Collaborators: Karolinska Institutet, University of Copenhagen, University of Glasgow, Technical University of Munich
Leads: University of Bergen

This content was sourced from clinicaltrials.gov