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Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes. The Hypo-energetic Study

NCT03814694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-01-27

No results posted yet for this study

Summary

Scientific evidence for the dietary treatment of type 2 diabetes (T2D) is insufficient, which is why the investigators aim to reform dietary recommendation to the overweight or obese patient with type 2 diabetes. This clinical study will examine the effect of a highly controlled hypo-energetic carbohydrate-reduced high-protein (CRHP) diet intervention under caloric restriction-induced body weight loss as a treatment modality in T2D. The investigators hypothesize that this intervention compared to the conventional diabetes (CD) diet with similar loss in body weight improves metabolic control and cardiovascular risk profile in T2D by:

* Reducing diurnal and postprandial glycaemia, thereby facilitating a significant reduction in HbA1c
* Reducing ectopic lipid deposits in liver, muscle and pancreas
* Improving lipid profile towards a less atherogenic profile
* Improving metabolic actions of insulin, through increased sensitivity and β-cell function
* Reducing diurnal blood pressure with no adverse effect on heart rate variability

Conditions

  • Diabetes Mellitus, Type 2
  • Overweight and Obesity

Interventions

DIETARY_SUPPLEMENT

CRHP Diet

Dietary macronutrient composition of 30 E% from carbohydrate, 30 E% from protein and 40 E% from fat

DIETARY_SUPPLEMENT

CD Diet

Dietary macronutrient composition of 50 E% from carbohydrate, 17 E% from protein and 33 E% from fat

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • University of Aarhus

    collaborator OTHER

  • The Danish Dairy Research Foundation, Denmark

    collaborator OTHER

  • Arla Foods

    collaborator INDUSTRY

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Steen B Haugaard, Professor · Dept. of Endocrinology, Copenhagen University Hospital Bispebjerg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2020-07-22
Completion
2020-12-30

Countries

  • Denmark

Study Locations

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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 NCT03814694 on ClinicalTrials.gov