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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)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Low carbohydrate meals

Standard carbohydrate meals

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Endocrinological Dept. Bispebjerg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Type 2 diabetic subjects

Prediabetic subjects

Healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

Insulin sensitivity

Insulin sensitivity as measured by the oral minimal model applied to the meal test

Secondary Outcome Measures

Full Information

NCT ID

NCT02472951

First Posted

June 12, 2015

Last Updated

March 1, 2018

Sponsor

Bispebjerg Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02472951

Brief 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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Type 2 diabetic subjects

Arm Type

Active Comparator

Arm Title

Prediabetic subjects

Arm Type

Active Comparator

Arm Title

Healthy subjects

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Low carbohydrate meals

Intervention Description

Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%

Intervention Type

Other

Intervention Name(s)

Standard carbohydrate meals

Intervention Description

Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%

Primary Outcome Measure Information:

Title

Insulin sensitivity

Description

Insulin sensitivity as measured by the oral minimal model applied to the meal test

Time Frame

Measured during meal tests (2 days with each intervention)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steen B Haugaard, MD, DMSc, associate prof.

Organizational Affiliation

Amager og Hvidovre Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Thure Krarup, MD, DMSc

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Amirsalar Samkani, MD

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Endocrinological Dept. Bispebjerg University Hospital

City

Copenhagen

State/Province

Zealand

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

36061897

Citation

Thomsen MN, Skytte MJ, Samkani A, Astrup A, Fenger M, Frystyk J, Hartmann B, Holst JJ, Larsen TM, Madsbad S, Magkos F, Rehfeld JF, Haugaard SB, Krarup T. Weight loss improves beta-cell function independently of dietary carbohydrate restriction in people with type 2 diabetes: A 6-week randomized controlled trial. Front Nutr. 2022 Aug 19;9:933118. doi: 10.3389/fnut.2022.933118. eCollection 2022.

Results Reference

derived

PubMed Identifier

32859328

Citation

Thomsen MN, Skytte MJ, Astrup A, Deacon CF, Holst JJ, Madsbad S, Krarup T, Haugaard SB, Samkani A. The clinical effects of a carbohydrate-reduced high-protein diet on glycaemic variability in metformin-treated patients with type 2 diabetes mellitus: A randomised controlled study. Clin Nutr ESPEN. 2020 Oct;39:46-52. doi: 10.1016/j.clnesp.2020.07.002. Epub 2020 Aug 1.

Results Reference

derived

PubMed Identifier

30591062

Citation

Samkani A, Skytte MJ, Anholm C, Astrup A, Deacon CF, Holst JJ, Madsbad S, Boston R, Krarup T, Haugaard SB. The acute effects of dietary carbohydrate reduction on postprandial responses of non-esterified fatty acids and triglycerides: a randomized trial. Lipids Health Dis. 2018 Dec 27;17(1):295. doi: 10.1186/s12944-018-0953-8.

Results Reference

derived

PubMed Identifier

29644957

Citation

Samkani A, Skytte MJ, Kandel D, Kjaer S, Astrup A, Deacon CF, Holst JJ, Madsbad S, Rehfeld JF, Haugaard SB, Krarup T. A carbohydrate-reduced high-protein diet acutely decreases postprandial and diurnal glucose excursions in type 2 diabetes patients. Br J Nutr. 2018 Apr;119(8):910-917. doi: 10.1017/S0007114518000521.

Results Reference

derived

Learn more about this trial

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

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