Mesoglycan, Vascular Reactivity and Metabolic Syndrome

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to characterize the action of mesoglycan on vascular endothelium through the non-invasive assessment of vascular reactivity humeral artery by comparing effects of mesoglycan on Flow Mediated Dilatation (FMD) of the humeral artery between a group of patients with metabolic syndrome assuming placebo and a group of patient with metabolic syndrome assuming mesoglycan; firstly after administration of the drug/placebo intramuscularly, and then, in a study of medium-term after oral intake of drug/placebo. The selection of patients with metabolic syndrome is related to the fact that this syndrome is associated with alterations in endothelial function and a high incidence of cardiovascular events. So it is a condition that offers the opportunity to explore the hypothesis that the mesoglycan may have a favorable effect on early vascular alterations that precede clinical events.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Carboxymethylcellulose Sodium; Titanium dioxide

Criteria

Inclusion Criteria:

3 or more of the following criteria of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III):

• Increased abdominal circumference ≥102 cm in man, ≥88 cm in women

• Triglycerides ≥150 mg / dL

• HDL-cholesterol <40 mg / dL in men, <50 mg / dL in women

• Systolic blood pressure> 130 mm Hg or diastolic blood pressure> 85 mm Hg

• Blood glucose> 100 mg / dL

Exclusion Criteria:

• Indication for cardiac surgery or surgeries performed by less than 3 months

• Under the age of 18 years

• Age greater than 65 years

• Inability to perform periodic inspections

• Presence of malignancy and serious heart diseases.

• Hemorrhagic diathesis and diseases.

• Hypersensitivity to mesoglycan, heparin and heparinoids.

• Type 1 diabetes and type 2

• Pregnancy and / or breastfeeding