Effects of Omega-3-Fatty Acids on Arterial Endothelial Function and Intima Media Thickness in Children with Insulin-Dependent Diabetes Mellitus

• Conditions: Diabetes mellitus type 1 in children

• Registration Number: EUCTR2006-004427-11-SE
• Lead Sponsor: niv of Lund, Dept of Pediatrics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Children with type 1 diabetes mellitus aged 10-18 years and with a diabetes duration greater than 1 year
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Obesity. Acute infectious illness. Passive or active smoking. Hypertension. Family history of premature coronary heart disease (onset in first degree relative <55 years males and <60 years females)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Objective is to test the eventual protective effect of omega-3 fatty acids in natural fishoil on arterial endothelium and intima media thickness in children with type 1 diabetes.<br>Studies from our group have shown that diabetic children early in the course of the disease have disturbances in the endothelium and intima media.<br>These disturbances can be followed by high resolution ultrasound techique;Secondary Objective: ;Primary end point(s): The patients endothelial function and intima media thickness are measured by ultrasound before, under and at the end of the study and differences in the values before and after the trial are calculated and compared.<br>Primary endpoint is % change from baseline of flowmediated artery dilatation (reflects the endothelium function) as a result of treatment.