Metabolic Syndrome. Other disorders of lipoprotein metabolism
Conditions
Interventions
Intervention 1: Omega-3 Capsule, 2000 mg ( containing 600 mg EPA/DHA) once daily for 8 weeks. Intervention 2: Vitamin E capsule, 400 IU once daily for 8 weeks. Intervention 3: Placebo capsule once dai
Treatment - Drugs
Omega-3 Capsule, 2000 mg ( containing 600 mg EPA/DHA) once daily for 8 weeks
Vitamin E capsule, 400 IU once daily for 8 weeks
Placebo capsule once daily for 8 weeks
Sponsors
Vice Chancellery for Research, Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Matching metabolic syndrome definition (based on the new definition of International Diabetes Federation (IDF) on October 2007) (The IDF consensus definition for children 10 to <16 years of age include the clustering of any three of the following risk factors: 1) obesity, waist circumference = 90% based on age and gender; 2) triglycerides = 150 mg/dL; 3) HDL- cholesterol < 40 mg/dL; 4) systolic blood pressure = 130/ diastolic blood pressure = 85 mmHg and 5) glucose = 100 mg/dL. For individuals over 16 years old, the adult definition should be applied.), undergoing at least 4 months of common therapies without significant response. Exclusion criteria: Possible drug side effects, no compliance for follow up
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Waist circumference. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Non elastic tape with accuracy of 0.1 cm.;Weight. Timepoint: at the beginning of the study and 8 weeks after intervention. Method of measurement: SECA medical scale with the accuracy of o.1 kg.;Height. Timepoint: at the beginning of the study. Method of measurement: SECA stadiometer with the accuracy of 0.1 cm.;Triglycerides(TG). Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Enzymatic.;Blood pressure. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Mercury sphygmomanometer wit the accuracy of 1mmHg.;High-density lipoprotein (HDL). Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Enzymatic.;Fasting Blood Sugar(FBS). Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Glucose Oxidase method.;BMI. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: calculated by the formula:weight/height2(kg/m2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Total cholesterol. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Enzymatic.;Low Density Lipoprotein(LDL). Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Directly.;Nitric Oxide(NO). Timepoint: At the begining of intervention and 8 weeks later. Method of measurement: ELISA.;Vascular Endothelial Growth Factor(VEGF). Timepoint: At the begining of intervention and 8 weeks later. Method of measurement: Sandwich ELISA method.;Fasting Insulin. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: ELISA.;Total Anti Oxidant Capacity in Plasma. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: calorimetery.;HOMA-IR. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: calculation.;Hs-CRP. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Immunoturbidimetry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoya Kelishadi
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Outcome results
None listed