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)

March 1, 2018 updated by: Amirsalar Samkani, Bispebjerg Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Zealand
      • Copenhagen, Zealand, Denmark, 2400
        • Endocrinological Dept. Bispebjerg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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%
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured during meal tests (2 days with each intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Study Director: Steen B Haugaard, MD, DMSc, associate prof., Amager og Hvidovre Hospital
  • Principal Investigator: Amirsalar Samkani, MD, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46559

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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