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Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes

NCT02764021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-03-02

No results posted yet for this study

Summary

Scientific evidence for the dietary treatment of type 2 diabetes (T2D) is insufficient. The study group hypothesizes that a lower carbohydrate content in the diabetic diet than the recommended 55 energy percentage (E%) will decrease the postprandial glucose excursion. This will reduce postprandial insulin concentration, which together with lower glucose concentration leads to less fat accumulation in the liver and muscle tissue, resulting in an improved insulin sensitivity which together with a reduced glucose load improves the glucose metabolism. This clinical study will examine in subjects with type 2 diabetes the effect of highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, ectopic fat accumulation, incretin hormones, low grade inflammation in plasma and adipose tissue, novel measures of fatty acid metabolism, and heart rate variability, respectively. The studies exhibit the potential to reform dietary recommendation aiming to prevent and ameliorate type 2 diabetes.

Conditions

Interventions

DIETARY_SUPPLEMENT

Carbohydrate-Restricted Diet

Macronutritional composition: Carbohydrate 30 E%, Protein 30 E%, Fat 40 E%

DIETARY_SUPPLEMENT

Standard Antidiabetic Diet

Macronutritional composition: Carbohydrate 50 E%, Protein 13 E%, Fat 17 E%

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • University of Aarhus

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Thure Krarup, MD, DMSc · Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT02764021 on ClinicalTrials.gov