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)

Bispebjerg Hospital

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Low carbohydrate meals; Other: Standard carbohydrate meals

Study type: Interventional

Funder types: Other

Identifiers

NCT02472951

46559

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Type 2 diabetic subjects

Active Comparator group

Treatment:

Other: Standard carbohydrate meals

Other: Low carbohydrate meals

Prediabetic subjects

Active Comparator group

Treatment:

Other: Standard carbohydrate meals

Other: Low carbohydrate meals

Healthy subjects

Active Comparator group

Treatment:

Other: Standard carbohydrate meals

Other: Low carbohydrate meals