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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Dietary supplement: Low carbohydrate - high fat diet; Dietary supplement: High carbohydrate - low fat diet

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Motala, Östergötland, Sweden, S-59185
      • Vårdcentralen Lyckorna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetes mellitus type 2

Exclusion Criteria:

• Severe psychiatric disease or difficulties in understanding Swedish language.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Laboratory findings and body composition	2 years

Collaborators and Investigators

• Sponsor: Vårdcentralen Lyckorna
• Investigators: Principal Investigator: Hans G Guldbrand, Vårdcentralen Lyckorna

Publications and helpful links

General Publications

• Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.
• Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
• Guldbrand H, Dizdar B, Bunjaku B, Lindstrom T, Bachrach-Lindstrom 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. doi: 10.1007/s00125-012-2567-4. Epub 2012 May 6.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 30, 2009
• First Submitted That Met QC Criteria: October 30, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 4, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Low carbohydrate diet. Dietary treatment of diabetes mellitus.; Diabetes mellitus type 2 and dietary treatment.
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: M216-08