Type 2 DiabetesCutDMNCT02472951
Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study
A study testing Low carbohydrate meals and Standard carbohydrate meals in people with Type 2 Diabetes, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Low carbohydrate meals and Standard carbohydrate meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Dec 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men age 18-70 years
- Postmenopausal women age 55-70 years
- Non-smoker (abstinent at least 6 months)
- HbA1c < 74 mmol/mol
- Fasting blood glucose < 11 mmol/L (mean of 3 measurements)
- Negative (<25 IU/L) plasma glutamate decarboxylase (GAD-65) antibodies (IgG)
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- Hemoglobin > 7.5 mmol/L (men); > 6.8 mmol/L (women)
- Normal thrombocytes (140-400 x 109/L)
- eGFR > 45 ml/min per 1.73 m2
- Alkaline phosphatase < 140 IU/L
- Alanine aminotransferase < 70 IU/L
- Normal International Normalized Ratio (0.9-1.2)
Who cannot join
- Critical illness
- Anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
- Steroid treatment e.g. prednisolone
- Reported or journalized severe food allergy or intolerance
- Reported or journalized gut disease e.g. Crohn's disease, Coeliac disease
- Reported or journalized alcohol dependence syndrome
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Endocrinological Dept. Bispebjerg University Hospital
Copenhagen, Region Sjælland, 2400
About this study
Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their insulinotropic effects due to their glucose dependency. This will reduce postprandial insulin concentration, resulting in an improved insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in plasma and novel measures of fatty acid metabolism.
- Conditions
- Type 2 Diabetes
- Being tested
- Low carbohydrate meals, Standard carbohydrate meals
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate mealsOther
Meal macronutritional energy composition:
Carbohydrate 30% Protein 30% Fat 40%
Standard carbohydrate mealsOther
Meal macronutritional energy composition:
Carbohydrate 55% Protein 15% Fat 30%
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic subjects | Active comparator | Not described Receives: Other: Low carbohydrate meals; Other: Standard carbohydrate meals |
| Prediabetic subjects | Active comparator | Not described Receives: Other: Low carbohydrate meals; Other: Standard carbohydrate meals |
| Healthy subjects | Active comparator | Not described Receives: Other: Low carbohydrate meals; Other: Standard carbohydrate meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity as measured by the oral minimal model applied to the meal test
Measured: Measured during meal tests (2 days with each intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amirsalar Samkani, Bispebjerg Hospital
- Investigators
- Steen B Haugaard, MD, DMSc, associate prof., Study director, Amager og Hvidovre hospitalThure Krarup, MD, DMSc, Study director, Bispebjerg HospitalAmirsalar Samkani, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472951
- Sponsor's protocol ID
- 46559
- Acronym
- CutDM
- Status last verified
- Mar 2018
- First submitted
- 12 Jun 2015
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thomsen MN, Skytte MJ, Samkani A, Astrup A, Fenger M, Frystyk J, Hartmann B, Holst JJ, Larsen TM, Madsbad S, Magkos F, Rehfeld JF, Haugaard SB, Krarup T. Weight loss improves beta-cell function independently of dietary carbohydrate restriction in people with type 2 diabetes: A 6-week randomized controlled trial. Front Nutr. 2022 Aug 19;9:933118. doi: 10.3389/fnut.2022.933118. eCollection 2022.
PubMed 36061897Thomsen MN, Skytte MJ, Astrup A, Deacon CF, Holst JJ, Madsbad S, Krarup T, Haugaard SB, Samkani A. The clinical effects of a carbohydrate-reduced high-protein diet on glycaemic variability in metformin-treated patients with type 2 diabetes mellitus: A randomised controlled study. Clin Nutr ESPEN. 2020 Oct;39:46-52. doi: 10.1016/j.clnesp.2020.07.002. Epub 2020 Aug 1.
PubMed 32859328Samkani A, Skytte MJ, Anholm C, Astrup A, Deacon CF, Holst JJ, Madsbad S, Boston R, Krarup T, Haugaard SB. The acute effects of dietary carbohydrate reduction on postprandial responses of non-esterified fatty acids and triglycerides: a randomized trial. Lipids Health Dis. 2018 Dec 27;17(1):295. doi: 10.1186/s12944-018-0953-8.
PubMed 30591062Samkani A, Skytte MJ, Kandel D, Kjaer S, Astrup A, Deacon CF, Holst JJ, Madsbad S, Rehfeld JF, Haugaard SB, Krarup T. A carbohydrate-reduced high-protein diet acutely decreases postprandial and diurnal glucose excursions in type 2 diabetes patients. Br J Nutr. 2018 Apr;119(8):910-917. doi: 10.1017/S0007114518000521.
PubMed 29644957
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study
- ClinicalTrials.gov ID
- NCT02472951
- Acronym / sponsor ID
- CutDM / 46559
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Jun 2015 (estimated)
- 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.
Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their insulinotropic effects due to their glucose dependency. This will reduce postprandial insulin concentration, resulting in an improved insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in plasma and novel measures of fatty acid metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic subjects | Active comparator | Other: Low carbohydrate meals, Other: Standard carbohydrate meals |
| Prediabetic subjects | Active comparator | Other: Low carbohydrate meals, Other: Standard carbohydrate meals |
| Healthy subjects | Active comparator | Other: Low carbohydrate meals, Other: Standard carbohydrate meals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men age 18-70 years
- Postmenopausal women age 55-70 years
- Non-smoker (abstinent at least 6 months)
- HbA1c < 74 mmol/mol
- Fasting blood glucose < 11 mmol/L (mean of 3 measurements)
Key exclusion criteria (6 listed)
- Critical illness
- Anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
- Steroid treatment e.g. prednisolone
- Reported or journalized severe food allergy or intolerance
- Reported or journalized gut disease e.g. Crohn's disease, Coeliac disease
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 |
|---|---|---|
| Low carbohydrate mealsMeal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40% | Other | Healthy subjects, Prediabetic subjects, Type 2 diabetic subjects |
| Standard carbohydrate mealsMeal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30% | Other | Healthy subjects, Prediabetic subjects, Type 2 diabetic subjects |
Primary outcome
Insulin sensitivity
Time frame: Measured during meal tests (2 days with each intervention)
Insulin sensitivity as measured by the oral minimal model applied to the meal test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Derived from this study: PubMed 36061897Thomsen MN, Skytte MJ, Samkani A, Astrup A, Fenger M, Frystyk J, Hartmann B, Holst JJ, Larsen TM, Madsbad S, Magkos F, Rehfeld JF, Haugaard SB, Krarup T. Weight loss improves beta-cell function independently of dietary carbohydrate restriction in people with type 2 diabetes: A 6-week randomized controlled trial. Front Nutr. 2022 Aug 19;9:933118. doi: 10.3389/fnut.2022.933118. eCollection 2022.
- Derived from this study: PubMed 32859328Thomsen MN, Skytte MJ, Astrup A, Deacon CF, Holst JJ, Madsbad S, Krarup T, Haugaard SB, Samkani A. The clinical effects of a carbohydrate-reduced high-protein diet on glycaemic variability in metformin-treated patients with type 2 diabetes mellitus: A randomised controlled study. Clin Nutr ESPEN. 2020 Oct;39:46-52. doi: 10.1016/j.clnesp.2020.07.002. Epub 2020 Aug 1.
- Derived from this study: PubMed 30591062Samkani A, Skytte MJ, Anholm C, Astrup A, Deacon CF, Holst JJ, Madsbad S, Boston R, Krarup T, Haugaard SB. The acute effects of dietary carbohydrate reduction on postprandial responses of non-esterified fatty acids and triglycerides: a randomized trial. Lipids Health Dis. 2018 Dec 27;17(1):295. doi: 10.1186/s12944-018-0953-8.
- Derived from this study: PubMed 29644957Samkani A, Skytte MJ, Kandel D, Kjaer S, Astrup A, Deacon CF, Holst JJ, Madsbad S, Rehfeld JF, Haugaard SB, Krarup T. A carbohydrate-reduced high-protein diet acutely decreases postprandial and diurnal glucose excursions in type 2 diabetes patients. Br J Nutr. 2018 Apr;119(8):910-917. doi: 10.1017/S0007114518000521.
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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.
Steen B Haugaard, MD, DMSc, associate prof. study director
Amager og Hvidovre hospital
Thure Krarup, MD, DMSc study director
Bispebjerg Hospital
Amirsalar Samkani, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate meals and Standard carbohydrate meals in people with Type 2 Diabetes, run by Bispebjerg 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 12 inclusion and 6 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: finished, as of the sponsor's last update on 2 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin sensitivity (time frame: Measured during meal tests (2 days with each intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02472951, which also lists 4 linked publications.
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 Mar 2018.