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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)

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ClinicalTrials.gov Identifier: NCT02472951
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Amirsalar Samkani, Bispebjerg Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Low carbohydrate meals Other: Standard carbohydrate meals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Type 2 diabetic subjects Other: Low carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%


Other: Standard carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%


Active Comparator: Prediabetic subjects Other: Low carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%


Other: Standard carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%


Active Comparator: Healthy subjects Other: Low carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 30% Protein 30% Fat 40%


Other: Standard carbohydrate meals

Meal macronutritional energy composition:

Carbohydrate 55% Protein 15% Fat 30%





Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472951


Locations
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Denmark
Endocrinological Dept. Bispebjerg University Hospital
Copenhagen, Zealand, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Study Director: Steen B Haugaard, MD, DMSc, associate prof. Amager og Hvidovre Hospital
Study Director: Thure Krarup, MD, DMSc Bispebjerg Hospital
Principal Investigator: Amirsalar Samkani, MD Bispebjerg Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amirsalar Samkani, MD, PhD-stud, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02472951    
Other Study ID Numbers: 46559
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases