Status:
COMPLETED
Mesoglycan, Vascular Reactivity and Metabolic Syndrome
Lead Sponsor:
Federico II University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 mesoglyc...
Detailed Description
The subjects were enrolled in a double blind randomized way, according to a 2: 1 ratio, to intramuscular treatment with mesoglycan or placebo. Patients performed the study of the Flow Mediated Dilatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02254850
Start Date
May 1 2013
End Date
June 1 2014
Last Update
October 2 2014
Active Locations (1)
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1
Ugo Oliviero
Via Pansini, 5, Napoli, Italy, 80131