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Dietary Strategies for Remission of Type 2 Diabetes

Study acronym: CARBCOUNT
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date changed from estimate of Dec 31, 2024 to Sep 10, 2026 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion moved earlier from Dec 31, 2040 to Jun 11, 2030
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 6 of 8 entries
    • Site details revised
  2. Minor Enrollment target: 750 to 600
    • Start date changed from estimate of Nov 8, 2021 to Jan 4, 2022
    • Study description revised
    • Eligibility criteria shortened, about 1 word
    v3
  3. Notable Start date: Aug 15, 2021 to Nov 8, 2021
    • Secondary endpoints revised (8)
    • Study description expanded, about 23 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
5,087 trials monitored
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3,874 trials monitored
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2,231 trials monitored
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and 1 more disease
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.
Trial Details
NCT Number NCT04943926
Lead Sponsor University of Bergen
Collaborators: Karolinska Institutet, University of Glasgow, University of Copenhagen, Technical University of Munich
Conditions
(from sponsor)
Diabetes Mellitus, Type 2, Overweight and Obesity, Hypertension, Glucose Intolerance, Insulin Resistance, Dyslipidemia Associated With Type II Diabetes Mellitus
Related terms Diabetes Mellitus, Type 2, Glucose Intolerance, Hypertension, Insulin Resistance, Obesity, Overweight
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov