Last reviewed · How we verify
NCT04943926: CARBCOUNT
Dietary Strategies for Remission of Type 2 Diabetes
NA trial testing Energy restricted diet in Diabetes Mellitus, Type 2 in 600 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | University of Bergen |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 600 |
| Start date | 4 January 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2040 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Energy restricted diet
- Low carbohydrate high fat diet
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Overweight and Obesity — all drugs for Overweight and Obesity →
- Hypertension — all drugs for Hypertension →
- Glucose Intolerance — all drugs for Glucose Intolerance →
Sponsor
University of Bergen
Who can join
Adults 24 to 70, any sex, with Diabetes Mellitus, Type 2 or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nutrition Interventions for Remission of Type 2 Diabetes: Potential Role for Diabetes-Specific Nutrition Formulas.
Trenell M, Bajaj H, Mechanick JI, Hamdy O. · · 2025 · cited 1× · PMID 40290837 · DOI 10.2337/cd24-0052 -
Tuned by time: the role of circadian rhythms in metabolic energy sensing and chronotherapy.
Thanuskodi Rajakumar A, Kodiveri Muthukaliannan G. · · 2025 · PMID 41339276 · DOI 10.1080/07853890.2025.2596548
Verify or expand the search:
- PubMed search for NCT04943926
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
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Other University of Bergen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04943926 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bergen
- Last refreshed: 8 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04943926.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing