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Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2. (VÄSTKOST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005498
First Posted: November 2, 2009
Last Update Posted: December 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hans Guldbrand, Vårdcentralen Lyckorna
  Purpose
The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.

Condition Intervention Phase
Diabetes Dietary Supplement: Low carbohydrate - high fat diet Dietary Supplement: High carbohydrate - low fat diet Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.

Resource links provided by NLM:


Further study details as provided by Hans Guldbrand, Vårdcentralen Lyckorna:

Primary Outcome Measures:
  • Laboratory findings and body composition [ Time Frame: 2 years ]

Enrollment: 61
Study Start Date: March 2009
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low carbohydrate diet (F)
The group attended to low carbohydrate diet
Dietary Supplement: Low carbohydrate - high fat diet
The diet has an energy content of 1600 kcal or 1800, with 50% from fat, 20% from carbohydrates and 30% from proteins.
Active Comparator: Traditional diet (K)
The group attended to traditional diet
Dietary Supplement: High carbohydrate - low fat diet
The diet has an energy content of 1600 or 1800 kcal, with 30% from fat, 55-60% from carbohydrates and 10-15% from proteins.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus type 2

Exclusion Criteria:

  • Severe psychiatric disease or difficulties in understanding Swedish language.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005498


Locations
Sweden
Vårdcentralen Lyckorna
Motala, Östergötland, Sweden, S-59185
Sponsors and Collaborators
Vårdcentralen Lyckorna
Investigators
Principal Investigator: Hans G Guldbrand Vårdcentralen Lyckorna
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans Guldbrand, Distriktsläkare, Vårdcentralen Lyckorna
ClinicalTrials.gov Identifier: NCT01005498     History of Changes
Other Study ID Numbers: M216-08
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by Hans Guldbrand, Vårdcentralen Lyckorna:
Low carbohydrate diet. Dietary treatment of diabetes mellitus.
Diabetes mellitus type 2 and dietary treatment.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases