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Strategie dietetyczne w celu remisji cukrzycy typu 2 (CARBCOUNT)

29 września 2026 zaktualizowane przez: University of Bergen

Strategie dietetyczne w celu uzyskania remisji cukrzycy typu 2 — randomizowana, kontrolowana próba (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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

600

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

24 lata do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Energy Restricted Diet

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

Nutritional complete formula diet followed by an energy restricted diet
Eksperymentalny: 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.
Inny: Low carbohydrate high fat diet

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Diabetes remission
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Diabetes remission without anti-diabetes medications
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Rates of T2D remission dependent on polygenic risk scores for T2D
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3, 9 and 15 months

Blood lipids measured in fasting blood samples
3, 9 and 15 months
Changes in lipoprotein subfractions from baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Bergen

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 stycznia 2022

Zakończenie podstawowe (Rzeczywisty)

10 września 2026

Ukończenie studiów (Szacowany)

11 czerwca 2030

Daty rejestracji na studia

Pierwszy przesłany

21 czerwca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 czerwca 2021

Pierwszy wysłany (Rzeczywisty)

29 czerwca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CARBCOUNT Multicenter RCT

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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