NCT01005498

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

October 30, 2009

Last Update Submit

December 4, 2011

Conditions

Keywords

Low carbohydrate diet. Dietary treatment of diabetes mellitus.Diabetes mellitus type 2 and dietary treatment.

Outcome Measures

Primary Outcomes (1)

  • Laboratory findings and body composition

    2 years

Study Arms (2)

Low carbohydrate diet (F)

EXPERIMENTAL

The group attended to low carbohydrate diet

Dietary Supplement: Low carbohydrate - high fat diet

Traditional diet (K)

ACTIVE COMPARATOR

The group attended to traditional diet

Dietary Supplement: High carbohydrate - low fat diet

Interventions

The diet has an energy content of 1600 kcal or 1800, with 50% from fat, 20% from carbohydrates and 30% from proteins.

Low carbohydrate diet (F)

The diet has an energy content of 1600 or 1800 kcal, with 30% from fat, 55-60% from carbohydrates and 10-15% from proteins.

Traditional diet (K)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus type 2

You may not qualify if:

  • Severe psychiatric disease or difficulties in understanding Swedish language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vårdcentralen Lyckorna

Motala, Östergötland County, S-59185, Sweden

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hans G Guldbrand

    Vårdcentralen Lyckorna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distriktsläkare

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2011

Study Completion

December 1, 2011

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations