Mesoglycan, Vascular Reactivity and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

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 Dilation (FMD) according to the following scheme:

        -  FMD baseline

        -  FMD 2 hours after the administration of 2 vials of mesoglycan or placebo intramuscularly

        -  FMD 6 hours after intramuscular administration.

      Nextly, both patients treated with mesoglycan vials and placebo vials continued therapy for
      assuming mesoglycan or placebo, per os, bis in die, for 90 days. At the end of this period of
      oral therapy (mesoglycan or placebo in a 2: 1 ratio), all patients performed FMD again. The
      patients who were taking any specific therapy (eg antihypertensive drugs) the Placebo was
      administered in addition to their standard therapy.

      The vascular reactivity evaluation adopted was the Flow Mediated Dilatation (FMD). After a
      period of fasting and rest for at least 6 hours, the study of FMD was performed using a
      high-resolution ultrasound system, equipped with a 7.5 Megahertz linear probe under ECG
      monitoring. After a rest period of at least 10 minutes on a bed in supine decubitus in an
      air-conditioned room, the sensor was placed on humeral artery, 3-5 cm above the elbow, and
      held the same position during the examination through an arm mechanically connected. They
      were performing a number of longitudinal sections and measured the internal diameter of the
      vessel, defined as the distance between the top edge of the echo produced by the interface
      between the lumen and the anterior wall of the vessel and the top edge of the echo produced
      by the interface between the lumen and the rear wall of the vessel. The inner diameter of the
      vessel was measured several times, on the R wave of the ECG, and a pc "software" calculated
      the average value. The flow rate was measured with the sample volume placed in the center of
      the vase with a 60 ° angle between the ultrasound beam and the longitudinal axis of the
      vessel. 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,
      always with a correction angle of 60 °, was recorded immediately after the desufflation; the
      diameter of the brachial artery, it 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 base of the vessel.
    

Intervention name(s): Flow Mediated Dilation; Mesoglycan; Mesoglycan; Placebo; Placebo
Intervention type(s): Procedure; Drug; Drug; Drug; Drug
Intervention description(s): 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.; The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml.; The patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing: Mesoglycan 50 mg.; The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.; 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.
Other intervention name(s): FMD; Mesoglycan Intramuscular injecion; Mesoglycan Oral Treatment; Placebo Intramuscular Injection; Placebo Oral Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Mesoglycan; Metabolic Syndrome; Flow Mediated Dilation