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NCT Number: NCT02472951

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinological Dept. Bispebjerg University Hospital

Copenhagen, Region Sjælland, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low carbohydrate meals

Other

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%

Standard carbohydrate meals

Other

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Acronym: CutDM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2015
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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