Mesoglycan, Vascular Reactivity and Metabolic Syndrome

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

August 31, 2013

Study Completion Date

June 30, 2014

Conditions
Metabolic Syndrome
Interventions
PROCEDURE

Flow Mediated Dilation

"Patients performed FMD by an high-resolution ultrasound linear probe in a supine decubitus and conditioned room.The probe was placed on humeral artery and connected to a mechanically arm. Then were performed several measurement s of the internal diameter of the vessel (edge to edge distance), on the R wave of the ECG, and software calculated the average value.The post-ischemic vasodilation was induced using a sphygmomanometer placed on the forearm, distal to the elbow crease, kept inflated to 250 mmHg for 5 minutes. The flow rate was recorded immediately after the desufflation; the diameter of the brachial artery was measured several times after desufflation (for 60-90 seconds). Nextly, the FMD was calculated as the percentage difference between the maximum diameter of the post-ischemic reached and the mean diameter of the vessel."

DRUG

Mesoglycan

The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml.

DRUG

Mesoglycan

The patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing: Mesoglycan 50 mg.

DRUG

Placebo

The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.

DRUG

Placebo

The patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing inactive ingredients: lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, erythrosine.

Trial Locations (1)

80131

Ugo Oliviero, Via Pansini, 5

All Listed Sponsors
lead

Federico II University

OTHER

NCT02254850 - Mesoglycan, Vascular Reactivity and Metabolic Syndrome | Biotech Hunter | Biotech Hunter