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:

Information provided by (Responsible Party):

Hans Guldbrand, Vårdcentralen Lyckorna

ClinicalTrials.gov Identifier:

NCT01005498

First received: October 30, 2009

Last updated: December 4, 2011

Last verified: December 2011

History of Changes

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: 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:

MedlinePlus related topics: Diabetes Diabetes Type 2 Diabetic Diet

U.S. FDA Resources

Further study details as provided by Vårdcentralen Lyckorna:

Primary Outcome Measures:

Laboratory findings and body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Vårdcentralen Lyckorna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Guldbrand H, Dizdar B, Bunjaku B, Lindström T, Bachrach-Lindström M, Fredrikson M, Ostgren CJ, Nystrom FH. In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss. Diabetologia. 2012 Aug;55(8):2118-27. Epub 2012 May 6.

Responsible Party:	Hans Guldbrand, Distriktsläkare, Vårdcentralen Lyckorna
ClinicalTrials.gov Identifier:	NCT01005498 History of Changes
Other Study ID Numbers:	M216-08
Study First Received:	October 30, 2009
Last Updated:	December 4, 2011
Health Authority:	Sweden: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013

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