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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02472951
• Date of registration: 12/06/2015
• Prospective Registration: Yes
• Primary sponsor: Bispebjerg Hospital
• Public 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 CutDM
• Scientific 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
• Date of first enrolment: August 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02472951
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Amirsalar Samkani, MD
• Affiliation: Bispebjerg Hospital

• Name: Thure Krarup, MD, DMSc
• Affiliation: Bispebjerg Hospital

• Name: Steen B Haugaard, MD, DMSc, associate prof.
• Affiliation: Amager og Hvidovre Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

- 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)

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Other: Standard carbohydrate meals

Other: Low carbohydrate meals

Primary Outcome(s)

Insulin sensitivity [Time Frame: Measured during meal tests (2 days with each intervention)]

Secondary ID(s)

46559

Source(s) of Monetary Support

Please refer to primary and secondary sponsors