Dietary Strategies for Remission of Type 2 Diabetes

NCT04943926 | Recruiting DMC

• 1 other identifier: CARBCOUNT Multicenter RCT
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Low-carbohydrate high-fat diet; Energy restricted diet; Lifestyle change; Ketogenic diet; Total meal replacement

Outcome Measures

Primary Outcomes (1)

• Diabetes remission

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

  15 months

Secondary Outcomes (8)

• Diabetes remission without anti-diabetes medications

  3, 9 and 15 months

• Changes in HbA1c and fasting glucose concentrations from baseline

  3, 9 and 15 months

• Changes in fasting insulin and insulin C-peptide concentrations from baseline

  3, 9 and 15 months

• Changes in estimated insulin resistance and beta cell function from baseline

  3, 9 and 15 months

• Changes from baseline in the frequency of diabetes- and antihypertensive medication usage

  3, 9 and 15 months

Other Outcomes (14)

• Rates of T2D remission dependent on polygenic risk scores for T2D

  3, 9 and 15 months

• Changes in ectopic fat accumulation from baseline

  3, 9 and 15 months

• Changes in liver fibrosis and steatosis from baseline

  3, 9 and 15 months

Study Arms (2)

Energy Restricted Diet

ACTIVE COMPARATOR

A nutritional complete formula diet for 3 months followed by an energy restricted diet for 12 months.

Other: Energy restricted diet

Continuous LCHF Diet

EXPERIMENTAL

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.

Other: Low carbohydrate high fat diet

Interventions

Energy restricted diet OTHER

Nutritional complete formula diet followed by an energy restricted diet

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)

Continuous LCHF Diet

Eligibility Criteria

• Age: 24 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Karolinska Institutet: collaborator
• University of Glasgow: collaborator
• University of Copenhagen: collaborator
• Technical University of Munich: collaborator

Study Sites (1)

Department of Clinical Science

Bergen, Vestland, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Hypertension; Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hyperglycemia; Hyperinsulinism

Central Study Contacts

Simon N Dankel, PhD

CONTACT

+4794308637; Simon.Dankel@uib.no

Kristin Amundsen, MSc

CONTACT

+4797171257; k.amundsen@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: We will use an independent statistician who will analyse the data anonymously and be blinded to information regarding dietary arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trail (RCT)

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: January 4, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2040
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)