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

Type 2 Diabetes Clinical Trial

— CutDM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472951
• Other study ID #: 46559
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: March 1, 2018
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Low carbohydrate meals
Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%
• Standard carbohydrate meals
Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%

Locations

Country	Name	City	State
Denmark	Endocrinological Dept. Bispebjerg University Hospital	Copenhagen	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Insulin sensitivity as measured by the oral minimal model applied to the meal test	Measured during meal tests (2 days with each intervention)