Diabetes Mellitus, Type 2CARBCOUNTNCT04943926
Dietary Strategies for Remission of Type 2 Diabetes
A study testing Energy restricted diet and Low carbohydrate high fat diet in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by University of Bergen at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight and Obesity, Hypertension
- What is being tested?
- Energy restricted diet and Low carbohydrate high fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNorway
- Study dates
- 4 Jan 2022to 11 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 2, Overweight and Obesity, Hypertension, Glucose Intolerance, Insulin Resistance, Dyslipidemia Associated With Type II Diabetes Mellitus
- Being tested
- Energy restricted diet, Low carbohydrate high fat diet
- Keywords
- Low-carbohydrate high-fat diet, Energy restricted diet, Lifestyle change, Ketogenic diet, Total meal replacement
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Hypertension, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy restricted dietOther
Nutritional complete formula diet followed by an energy restricted diet
Low carbohydrate high fat dietOther
Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)
| Study group | Role | What they receive |
|---|---|---|
| Energy Restricted Diet | Active comparator | A nutritional complete formula diet for 3 months followed by an energy restricted diet for 12 months. Receives: 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. Receives: Other: Low carbohydrate high fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Secondary outcomes (8)
Diabetes remission without anti-diabetes medications
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.)
Measured: 3, 9 and 15 months
Changes in HbA1c and fasting glucose concentrations from baseline
HbA1c and fasting glucose concentrations (treatment targets in current clinical practice) measured in fasting blood samples
Measured: 3, 9 and 15 months
Changes in fasting insulin and insulin C-peptide concentrations from baseline
Insulin and insulin C-peptide measured in fasting blood samples
Measured: 3, 9 and 15 months
Changes in estimated insulin resistance and beta cell function from baseline
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
Measured: 3, 9 and 15 months
Changes from baseline in the frequency of diabetes- and antihypertensive medication usage
The number of diabetes- and antihypertensive medications used/reintroduced by each study visit counted and compared between groups
Measured: 3, 9 and 15 months
Changes in eating behaviour from baseline and throughout the study
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.
Measured: 3, 9 and 15 months
Changes in eating self-efficacy (Three-Factor Eating Questionnaire, TFEQ)
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.
Measured: 3, 9 and 15 months
Changes in quality of life
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.
Measured: 3, 9 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start4 Jan 2022
- Primary completion10 Sep 2026
- Study completion11 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trail (RCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, University of Glasgow, University of Copenhagen, Technical University of Munich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943926
- Sponsor's protocol ID
- CARBCOUNT Multicenter RCT
- Acronym
- CARBCOUNT
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)
- ClinicalTrials.gov ID
- NCT04943926
- Acronym / sponsor ID
- CARBCOUNT / CARBCOUNT Multicenter RCT
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Karolinska Institutet, University of Glasgow, University of Copenhagen, Technical University of Munich
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 11 Jun 2030 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trail (RCT)
| Arm | Type | Receives |
|---|---|---|
| Energy Restricted Diet | Active comparator | Other: Energy restricted dietA nutritional complete formula diet for 3 months followed by an energy restricted diet for 12 months. |
| Continuous LCHF Diet | Experimental | Other: Low carbohydrate high fat dietA very low-carbohydrate high-fat ketogenic diet (VLCHF) diet for 3 months, followed by a low-carbohydrate high-fat diet (LCHF) for 12 months. |
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy restricted dietNutritional complete formula diet followed by an energy restricted diet | Other | Energy Restricted Diet |
| Low carbohydrate high fat dietVery low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF) | Other | Continuous LCHF Diet |
Primary outcome
Diabetes remission
Time frame: 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
8 secondary outcomes
Diabetes remission without anti-diabetes medications
Time frame: 3, 9 and 15 months
Changes in HbA1c and fasting glucose concentrations from baseline
Time frame: 3, 9 and 15 months
Changes in fasting insulin and insulin C-peptide concentrations from baseline
Time frame: 3, 9 and 15 months
Changes in estimated insulin resistance and beta cell function from baseline
Time frame: 3, 9 and 15 months
Changes from baseline in the frequency of diabetes- and antihypertensive medication usage
Time frame: 3, 9 and 15 months
Changes in eating behaviour from baseline and throughout the study
Time frame: 3, 9 and 15 months
Changes in eating self-efficacy (Three-Factor Eating Questionnaire, TFEQ)
Time frame: 3, 9 and 15 months
Changes in quality of life
Time frame: 3, 9 and 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy restricted diet and Low carbohydrate high fat diet in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes remission (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.