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

Diabetes Clinical Trial

— VÄSTKOST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005498
• Other study ID #: M216-08
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 30, 2009
• Last updated: December 4, 2011
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Vårdcentralen Lyckorna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diabetes mellitus type 2

Exclusion Criteria:

• Severe psychiatric disease or difficulties in understanding Swedish language.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Vårdcentralen Lyckorna	Motala	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Vårdcentralen Lyckorna

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory findings and body composition		2 years	No