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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004427-11-SE

Enrollment

Registered

2006-09-07

Start date

2006-10-27

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 1 in children

Interventions

Trade Name: Nycoplus Omega-3 Naturmiddel The product is not a medicinal substance but a freely available food additive Omega-3 fatty acids are considered the active substance Product Name: Nycoplus Om

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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. Studies from our group have shown that diabetic children early in the course of the disease have disturbances in the endothelium and intima media. 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. Primary endpoint is % change from baseline of flowmediated artery dilatation (reflects the endothelium function) as a result of treatment.	—

Measure

Time frame

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. Studies from our group have shown that diabetic children early in the course of the disease have disturbances in the endothelium and intima media. 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. Primary endpoint is % change from baseline of flowmediated artery dilatation (reflects the endothelium function) as a result of treatment.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026