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Strategie dietetiche per la remissione del diabete di tipo 2 (CARBCOUNT)

29 settembre 2026 aggiornato da: University of Bergen

Strategie dietetiche per la remissione del diabete di tipo 2 - uno studio controllato randomizzato (CARBCOUNT)

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

At least 588 patients with T2D will be recruited, approximately 120-150 men and women at each research center. The participants will be randomised to 1) a nutritional complete formula diet for 3 months followed by an energy restricted diet for 12 months or 2) a very low-carbohydrate high-fat (VLCHF) diet for 3 months, followed by a low-carbohydrate high-fat diet (LCHF) for 12 months. Each of the diets will cover all basic requirements for essential nutrients including amino acids, fatty acids, vitamins and minerals. Participants will be encouraged to consume at least 200 g of vegetables per day. Furthermore, we will emphasize high-quality, minimally processed foods. In arm 2 they will receive advice to eat specific fat sources such as extra virgin olive oil, butter and high-fat cheeses.

The DiRECT trial showed remission in 46% of participants after 12 months. Assuming that both the DiRECT program and LCHF dietary strategies yield a 45% chance of T2D remission after 15 months, it is calculated (using nQuery v8) that each group needs 235 participants to complete the trial. This sample size yields 90% statistical power to conclude, with respect to the primary outcome, whether the CarbCount Program is no more than 15% more or less effective than the DiRECT principles (equivalence study, one-sided p-value at 0.025). To allow for expected loss to follow-up (estimated at 20%), each of the arms needs at least 294 participants for a total of 588.

Participants will have access to electronic platforms that include an online database of recipes (breakfast, easy-to-cook lunches, snacks, dinners, and food for special occasions). The platforms will facilitate planning of week menus, and include an e-learning course covering topics such as how to cook and prepare foods, meal planning, dining out, sleep and individual aspects that challenge habit change. If the participants are failing in their efforts to establish or maintain lifestyle change, they will be encouraged to seek possible solutions in the e-learning courses or to contact one of the study's health educators and/or dietitians. Specific rescue plans involving direct contact with study staff will be implemented if a participant regains more than 2 kg or experiences T2D relapse.

After individual assessment by a doctor, the participants will be taken off diabetes medication upon starting the diet, and be asked to self-monitor blood sugar changes during the first 2 weeks on the diet, followed by a consultation that includes evaluation of these changes. The need of reintroduction of medication will be done in consultation with the study doctor at least every 3 months.

Between visits, the participants will complete dietary assessments and an e-learning course, and at least once a month have follow-ups with dietitians/health educators and/or online group workshops.

The study will enroll eligible participants to the study continuously, until the total number of participants needed for the study is reached. Each participant will follow their own timeline, and attend visits at the study center at baseline, 3, 9 and 15 months.

During 2 weeks before each visit, participants will wear a continuous glucose monitor (CGM) and record food intake for at least 3 consecutive days during this period.

Measurements during visits will include anthropometric variables/body composition and energy expenditure, blood, saliva, urine and stool samples will be collected, and participants will be asked to fill out questionnaires on physical activity, sleep pattern, meal frequency, quality of life, problem areas in diabetes, eating efficacy and eating behaviors. They will also have a consultation with a registered dietitian and meet with the study medical doctor when needed.

A blinded statistician will perform the statistical analyses for the primary outcome of the study.

Tipo di studio

Interventistico

Iscrizione (Stimato)

600

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Norvegia
    • Vestland
      • Bergen, Vestland, Norvegia, 5021
        • Department of Clinical Science

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 24 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Energy Restricted Diet

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

Nutritional complete formula diet followed by an energy restricted diet
Sperimentale: 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.
Altro: Low carbohydrate high fat diet

Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diabetes remission
Lasso di tempo: 15 months

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diabetes remission without anti-diabetes medications
Lasso di tempo: 3, 9 and 15 months

Number of patients with HbA1c <48 and <42 mmol/mol at 3, 9 and 15 months, both on and off anti-diabetes medication (metformin etc.)
3, 9 and 15 months
Changes in HbA1c and fasting glucose concentrations from baseline
Lasso di tempo: 3, 9 and 15 months

HbA1c and fasting glucose concentrations (treatment targets in current clinical practice) measured in fasting blood samples
3, 9 and 15 months
Changes in fasting insulin and insulin C-peptide concentrations from baseline
Lasso di tempo: 3, 9 and 15 months

Insulin and insulin C-peptide measured in fasting blood samples
3, 9 and 15 months
Changes in estimated insulin resistance and beta cell function from baseline
Lasso di tempo: 3, 9 and 15 months

The HOMA2-calculator (https://www.dtu.ox.ac.uk/homacalculator/download.php) is used to estimate insulin resistance and beta cell function based on fasting glucose and C-peptide concentrations
3, 9 and 15 months
Changes from baseline in the frequency of diabetes- and antihypertensive medication usage
Lasso di tempo: 3, 9 and 15 months

The number of diabetes- and antihypertensive medications used/reintroduced by each study visit counted and compared between groups
3, 9 and 15 months
Changes in eating behaviour from baseline and throughout the study
Lasso di tempo: 3, 9 and 15 months

Eating behaviour measured by the The Weight Efficacy Lifestyle Questionnaire - Short form (WEL-SF). The questionnaire contains 8 items on a 10-point response scale (ranging from not at all confident/very confident). Responses to each item are given a score between 0-10, summed together and transformed to percentages. Changes in these scores will be compared between the study groups for the respective time-points throughout the intervention.
3, 9 and 15 months
Changes in eating self-efficacy (Three-Factor Eating Questionnaire, TFEQ)
Lasso di tempo: 3, 9 and 15 months

Eating self-efficacy assessed by the Three-Factor Eating Questionnaire (TFEQ), which measures 3 aspects of eating behaviour: cognitive restraint, uncontrolled eating, and emotional eating. The questionnaire consists of 18 items on a 4-point response scale ( ranging from definitely true/mostly true/mostly false/definitely false). Responses to each item are given a score between 1 and 4 and and total scores are summed by the 3 measured aspects mentioned above. The raw scale scores are transformed to a 0-100 scale. Changes in these scores will be compared between the study groups for the respective time-points throughout the intervention.
3, 9 and 15 months
Changes in quality of life
Lasso di tempo: 3, 9 and 15 months

Quality of life measured by the EQ-5D-5L questionnaire, which includes 5 dimensions: mobility, self-care, usual activities, pain /discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The levels are scored with a 1-digit number and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. We will compare change at all timepoints between groups using both the 1-digit and the 5-digit number.

The questionnaire includes the patient's self-rated health on a Visual analog scale (VAS) ranging from 0-100. The endpoints are labelled "The best health you can imagine" and "The worst health you can imagine". The scale will be transposed into percentages and the percent change will be compared between the study groups.
3, 9 and 15 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Rates of T2D remission dependent on polygenic risk scores for T2D
Lasso di tempo: 3, 9 and 15 months

Polygenic risk scores are calculated based on the latest GWAS data for T2D, and rates of remission compared between patients with the top 20% high- and top 20% low scores, for all participants combined and the respective diets separately
3, 9 and 15 months
Changes in ectopic fat accumulation from baseline
Lasso di tempo: 3, 9 and 15 months

Body fat measured by MRI (abdominal adipose tissue distribution, hepatic-, intramuscular-, pericardial- and pancreatic fat)
3, 9 and 15 months
Changes in liver fibrosis and steatosis from baseline
Lasso di tempo: 3, 9 and 15 months

Liver fibrosis and steatosis measured by ultrasound-based transient elastography
3, 9 and 15 months
Changes in markers of liver function from baseline
Lasso di tempo: 3, 9 and 15 months

Alanine transaminase (ALT), C-reactive protein (CRP) and other markers of liver function measured in fasting blood samples
3, 9 and 15 months
Changes in inflammatory markers from baseline
Lasso di tempo: 3, 9 and 15 months

Circulating concentrations of selected markers of inflammation measured in fasting blood samples by ELISA
3, 9 and 15 months
Changes in blood pressure and pulse from baseline
Lasso di tempo: 3, 9 and 15 months

Blood pressure and pulse measured after 10 minutes in resting position
3, 9 and 15 months
Change in CVD risk (NORRISK) from baseline
Lasso di tempo: 3, 9 and 15 months

NORRISK calculated by the most current NORRISK calculator (https://hjerterisiko.helsedirektoratet.no/)
3, 9 and 15 months
Changes in total-, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and very-low-density (VLDL) cholesterol concentrations from baseline
Lasso di tempo: 3, 9 and 15 months

Blood lipids measured in fasting blood samples
3, 9 and 15 months
Changes in triacylglycerols (TGs) and TG/HDL-C ratio from baseline
Lasso di tempo: 3, 9 and 15 months

Blood lipids measured in fasting blood samples
3, 9 and 15 months
Changes in lipoprotein subfractions from baseline
Lasso di tempo: 3, 9 and 15 months

Lipoprotein particle numbers and sizes (small/medium/large LDL, IDL, HDL, VLDL) measured in fasting blood samples
3, 9 and 15 months
Changes in apolipoproteins from baseline
Lasso di tempo: 3, 9 and 15 months

Apolipoproteins (including apoB, apoAs, ApoCs) measured in fasting blood samples
3, 9 and 15 months
Changes in micronutrient status from baseline
Lasso di tempo: 3, 9 and 15 months

Micronutrients measured in the circulation in fasting blood samples
3, 9 and 15 months
Changes in gut and oral microbiota from baseline
Lasso di tempo: 3, 9 and 15 months

Gut and oral microbiota measured by 16S sequencing in feces and saliva, respectively
3, 9 and 15 months
Changes in appetite/satiety and ketones from baseline
Lasso di tempo: 3, 9 and 15 months

Ghrelin and ketones measured in fasting blood samples, and correlations in the change of ghrelin and ketones (beta-hydroxybutyrate and acetoacetate) from baseline.
3, 9 and 15 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Bergen

Collaboratori

Karolinska Institutet
University of Copenhagen
Technical University of Munich
University of Glasgow

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 gennaio 2022

Completamento primario (Effettivo)

10 settembre 2026

Completamento dello studio (Stimato)

11 giugno 2030

Date di iscrizione allo studio

Primo inviato

21 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2021

Primo Inserito (Effettivo)

29 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CARBCOUNT Multicenter RCT

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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