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

INTERVENTION: 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 Omega‐3 Naturmiddel Product Code: Not appl Pharmaceutical Form: Capsule, soft INN or Proposed INN: Not appl CAS Number: Not appl Current Sponsor code: Not appl Other descriptive name: Not appl Other descriptive name: Omega‐3 fatty acids Concentration unit: g gram(s) Concentration type: equal Concentration number: 0,54 g/g fishoil‐ Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use CONDITION: Diabetes mellitus type 1 in children PRIMARY OUTCOME: 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 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. Secondary Objective: 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