Diabetes Mellitus, Type 2INTERCARBNCT06144593
The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
A study testing Dietary macronutrient composition in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight and Obesity, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Dietary macronutrient composition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women
- 35-75 years old
- BMI >27 kg/m2
- Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c >48 mmol/mol if no glucose lowering therapy
Who cannot join
- Anemia (hemoglobin <8 mmol/L for men and <7 mmol/L for women)
- TSH outside reference range
- Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
- Treatment with systemic corticosteroids
- HbA1c >70 mmol/mol
- eGFR <60 ml/min/1.73 m2
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- Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
- Food allergies (including lactose and gluten intolerance)
- Vegetarian/vegan diet or following of specific dietary plans
- Alcohol consumptions >84/168 g/week (women/men)
- Strenuous activity level > 120 minutes per week
- Weight loss (>5 kg) within the last three months or previous bariatric surgery
- High risk of fibrosis of the liver (estimated by FIB4 score > 3.25)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Hvidovre Hospital
Hvidovre, 2650
Kirstine Nyvold Bojsen-Møller, MD, PhD
About this study
The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.
- Conditions
- Diabetes Mellitus, Type 2, Overweight and Obesity, Non-Alcoholic Fatty Liver Disease, Metabolic Syndrome
- Being tested
- Dietary macronutrient composition
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary macronutrient compositionOther
Intermittent carbohydrate restriction
| Study group | Role | What they receive |
|---|---|---|
| Intermittent carbohydrate restriction | Experimental | Four weeks of intermittent carbohydrate restriction: a dietary regime alternating between two days of restricting carbohydrate intake to 70-90 grams, while energy intake is ad libitum, from fat- and protein-containing foods, and two days of non-restricted diet. Receives: Other: Dietary macronutrient composition |
| Control arm | No intervention | Four weeks of free-living with no dietary restrictions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour average sensor glucose
A patient-blinded continuous glucose monitoring (CGM) is worn during the last two weeks of both the intervention and control period.
Measured: 24-hour average sensor glucose is measured as the average of eight consecutive days (starting from two days post sensor mounting) from the intermittent carbohydrate restriction period and the corresponding days of the control period (i.e. days 17-24).
Secondary outcomes (2)
Liver triacylglycerol content
Liver TG content will be measured by 1H-Magnetic Resonance Spectroscopy (MRS) on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30).
Measured: day 30 adjusted for baseline
Fasting plasma concentrations of triacylglycerols
Fasting plasma concentrations of triacylglycerols measured on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30).
Measured: day 30 adjusted for baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start3 Jan 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Dietary intervention
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Danish Research Centre for Magnetic Resonance
- Responsible party
- Principal investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144593
- Sponsor's protocol ID
- INTERCARB - H-23043085
- Acronym
- INTERCARB
- Status last verified
- Jun 2024
- First submitted
- 29 Sep 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06144593
- Acronym / sponsor ID
- INTERCARB / INTERCARB - H-23043085
- Conditions
- Diabetes Mellitus, Type 2, Overweight and Obesity, Non-Alcoholic Fatty Liver Disease, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Danish Research Centre for Magnetic Resonance
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 22 Nov 2023 (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.
The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dietary intervention
| Arm | Type | Receives |
|---|---|---|
| Intermittent carbohydrate restriction | Experimental | Other: Dietary macronutrient compositionFour weeks of intermittent carbohydrate restriction: a dietary regime alternating between two days of restricting carbohydrate intake to 70-90 grams, while energy intake is ad libitum, from fat- and protein-containing foods, and two days of non-restricted diet. |
| Control arm | No intervention | –Four weeks of free-living with no dietary restrictions. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women
- 35-75 years old
- BMI >27 kg/m2
- Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c >48 mmol/mol if no glucose lowering therapy
Key exclusion criteria (13 listed)
- Anemia (hemoglobin <8 mmol/L for men and <7 mmol/L for women)
- TSH outside reference range
- Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
- Treatment with systemic corticosteroids
- HbA1c >70 mmol/mol
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 |
|---|---|---|
| Dietary macronutrient compositionIntermittent carbohydrate restriction | Other | Intermittent carbohydrate restriction |
Primary outcome
24-hour average sensor glucose
Time frame: 24-hour average sensor glucose is measured as the average of eight consecutive days (starting from two days post sensor mounting) from the intermittent carbohydrate restriction period and the corresponding days of the control period (i.e. days 17-24).
A patient-blinded continuous glucose monitoring (CGM) is worn during the last two weeks of both the intervention and control period.
2 secondary outcomes
Liver triacylglycerol content
Time frame: day 30 adjusted for baseline
Fasting plasma concentrations of triacylglycerols
Time frame: day 30 adjusted for baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary macronutrient composition in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Schaufuss, MSc (+4530270261, amanda.schaufuss@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour average sensor glucose (time frame: 24-hour average sensor glucose is measured as the average of eight consecutive days (starting from two days post sensor mounting) from the intermittent carbohydrate restriction period and the corresponding days of the control period (i.e. days 17-24).). 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 6 Jun 2024.