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

NCT02472951 | Completed DMC

• 1 other identifier: 46559
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

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

  Measured during meal tests (2 days with each intervention)

Study Arms (3)

Type 2 diabetic subjects

ACTIVE COMPARATOR

Other: Low carbohydrate meals; Other: Standard carbohydrate meals

Prediabetic subjects

ACTIVE COMPARATOR

Other: Low carbohydrate meals; Other: Standard carbohydrate meals

Healthy subjects

ACTIVE COMPARATOR

Other: Low carbohydrate meals; Other: Standard carbohydrate meals

Interventions

Low carbohydrate meals OTHER

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

Healthy subjects; Prediabetic subjects; Type 2 diabetic subjects

Standard carbohydrate meals OTHER

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

Healthy subjects; Prediabetic subjects; Type 2 diabetic subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Endocrinological Dept. Bispebjerg University Hospital

Copenhagen, Region Sjælland, 2400, Denmark

Location

Related Publications (4)

• 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.

  PMID: 36061897 DERIVED

• 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.

  PMID: 32859328 DERIVED

• 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.

  PMID: 30591062 DERIVED

• 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.

  PMID: 29644957 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Steen B Haugaard, MD, DMSc, associate prof.

  Amager og Hvidovre Hospital

  STUDY DIRECTOR

• Thure Krarup, MD, DMSc

  Bispebjerg Hospital

  STUDY DIRECTOR

• Amirsalar Samkani, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-stud

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 2, 2018

Record last verified: 2018-03

Locations

DK (1)