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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

NCT02472951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-03-02

No results posted yet for this study

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

Interventions

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%

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Steen B Haugaard, MD, DMSc, associate prof. · Amager og Hvidovre Hospital

  • Thure Krarup, MD, DMSc · Bispebjerg Hospital

  • Amirsalar Samkani, MD · Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Denmark

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472951 on ClinicalTrials.gov