<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02254850</url>
  </required_header>
  <id_info>
    <org_study_id>Mesoglicano 29/13</org_study_id>
    <nct_id>NCT02254850</nct_id>
  </id_info>
  <brief_title>Mesoglycan, Vascular Reactivity and Metabolic Syndrome</brief_title>
  <official_title>The Mesoglycan and Vascular Reactivity in the Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study was to characterize the action of mesoglycan on vascular endothelium&#xD;
      through the non-invasive assessment of vascular reactivity humeral artery by comparing&#xD;
      effects of mesoglycan on Flow Mediated Dilatation (FMD) of the humeral artery between a group&#xD;
      of patients with metabolic syndrome assuming placebo and a group of patient with metabolic&#xD;
      syndrome assuming mesoglycan; firstly after administration of the drug/placebo&#xD;
      intramuscularly, and then, in a study of medium-term after oral intake of drug/placebo. The&#xD;
      selection of patients with metabolic syndrome is related to the fact that this syndrome is&#xD;
      associated with alterations in endothelial function and a high incidence of cardiovascular&#xD;
      events. So it is a condition that offers the opportunity to explore the hypothesis that the&#xD;
      mesoglycan may have a favorable effect on early vascular alterations that precede clinical&#xD;
      events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects were enrolled in a double blind randomized way, according to a 2: 1 ratio, to&#xD;
      intramuscular treatment with mesoglycan or placebo. Patients performed the study of the Flow&#xD;
      Mediated Dilation (FMD) according to the following scheme:&#xD;
&#xD;
        -  FMD baseline&#xD;
&#xD;
        -  FMD 2 hours after the administration of 2 vials of mesoglycan or placebo intramuscularly&#xD;
&#xD;
        -  FMD 6 hours after intramuscular administration.&#xD;
&#xD;
      Nextly, both patients treated with mesoglycan vials and placebo vials continued therapy for&#xD;
      assuming mesoglycan or placebo, per os, bis in die, for 90 days. At the end of this period of&#xD;
      oral therapy (mesoglycan or placebo in a 2: 1 ratio), all patients performed FMD again. The&#xD;
      patients who were taking any specific therapy (eg antihypertensive drugs) the Placebo was&#xD;
      administered in addition to their standard therapy.&#xD;
&#xD;
      The vascular reactivity evaluation adopted was the Flow Mediated Dilatation (FMD). After a&#xD;
      period of fasting and rest for at least 6 hours, the study of FMD was performed using a&#xD;
      high-resolution ultrasound system, equipped with a 7.5 Megahertz linear probe under ECG&#xD;
      monitoring. After a rest period of at least 10 minutes on a bed in supine decubitus in an&#xD;
      air-conditioned room, the sensor was placed on humeral artery, 3-5 cm above the elbow, and&#xD;
      held the same position during the examination through an arm mechanically connected. They&#xD;
      were performing a number of longitudinal sections and measured the internal diameter of the&#xD;
      vessel, defined as the distance between the top edge of the echo produced by the interface&#xD;
      between the lumen and the anterior wall of the vessel and the top edge of the echo produced&#xD;
      by the interface between the lumen and the rear wall of the vessel. The inner diameter of the&#xD;
      vessel was measured several times, on the R wave of the ECG, and a pc &quot;software&quot; calculated&#xD;
      the average value. The flow rate was measured with the sample volume placed in the center of&#xD;
      the vase with a 60 ° angle between the ultrasound beam and the longitudinal axis of the&#xD;
      vessel. The post-ischemic vasodilation was induced using a sphygmomanometer placed on the&#xD;
      forearm, distal to the elbow crease, kept inflated to 250 mmHg for 5 minutes. The flow rate,&#xD;
      always with a correction angle of 60 °, was recorded immediately after the desufflation; the&#xD;
      diameter of the brachial artery, it was measured several times after desufflation (for 60-90&#xD;
      seconds). Nextly, the FMD was calculated as the percentage difference between the maximum&#xD;
      diameter of the post-ischemic reached and the mean diameter of the base of the vessel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of FMD</measure>
    <time_frame>90 days</time_frame>
    <description>Verify if taken chronically mesoglycan 1 cp morning and evening for 90 days change compared to placebo vascular reactivity in subjects with metabolic syndrome (increased FMD in the treated group compared to baseline after 90 days of therapy) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of FMD</measure>
    <time_frame>2 and 6 hours</time_frame>
    <description>Verify if the mesoglycan administered intramuscularly change the vascular reactivity compared to placebo in subjects with metabolic syndrome (increased FMD from baseline in 2 and 6 hours after intramuscular administration)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Mesoglycan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml and inactive ingredients: sodium chloride, chlorocresol, water for injections.&#xD;
Nextly the patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing: Mesoglycan 50 mg and Inactive ingredients: lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, erythrosine.&#xD;
Patients also performed Flow Mediated Dilation (FMD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.&#xD;
Nextly 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.&#xD;
Patients also performed Flow Mediated Dilation (FMD).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Flow Mediated Dilation</intervention_name>
    <description>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 &quot;software&quot; 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.</description>
    <arm_group_label>Mesoglycan</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>FMD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesoglycan</intervention_name>
    <description>The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml.</description>
    <arm_group_label>Mesoglycan</arm_group_label>
    <other_name>Mesoglycan Intramuscular injecion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesoglycan</intervention_name>
    <description>The patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing: Mesoglycan 50 mg.</description>
    <arm_group_label>Mesoglycan</arm_group_label>
    <other_name>Mesoglycan Oral Treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo Intramuscular Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo Oral Treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        3 or more of the following criteria of the National Cholesterol Education Program (NCEP)&#xD;
        Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults&#xD;
        (Adult Treatment Panel III):&#xD;
&#xD;
          -  Increased abdominal circumference ≥102 cm in man, ≥88 cm in women&#xD;
&#xD;
          -  Triglycerides ≥150 mg / dL&#xD;
&#xD;
          -  HDL-cholesterol &lt;40 mg / dL in men, &lt;50 mg / dL in women&#xD;
&#xD;
          -  Systolic blood pressure&gt; 130 mm Hg or diastolic blood pressure&gt; 85 mm Hg&#xD;
&#xD;
          -  Blood glucose&gt; 100 mg / dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication for cardiac surgery or surgeries performed by less than 3 months&#xD;
&#xD;
          -  Under the age of 18 years&#xD;
&#xD;
          -  Age greater than 65 years&#xD;
&#xD;
          -  Inability to perform periodic inspections&#xD;
&#xD;
          -  Presence of malignancy and serious heart diseases.&#xD;
&#xD;
          -  Hemorrhagic diathesis and diseases.&#xD;
&#xD;
          -  Hypersensitivity to mesoglycan, heparin and heparinoids.&#xD;
&#xD;
          -  Type 1 diabetes and type 2&#xD;
&#xD;
          -  Pregnancy and / or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ugo Oliviero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federico II University-Dipartimento di Scienze Mediche Traslazionali</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ugo Oliviero</name>
      <address>
        <city>Via Pansini, 5</city>
        <state>Napoli</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available. Erratum In: Circulation. 2005 Oct 25;112(17):e297. Circulation. 2005 Oct 25;112(17):e298.</citation>
    <PMID>16157765</PMID>
  </reference>
  <reference>
    <citation>Reaven G. The metabolic syndrome or the insulin resistance syndrome? Different names, different concepts, and different goals. Endocrinol Metab Clin North Am. 2004 Jun;33(2):283-303. doi: 10.1016/j.ecl.2004.03.002.</citation>
    <PMID>15158520</PMID>
  </reference>
  <reference>
    <citation>Balkau B, Charles MA. Comment on the provisional report from the WHO consultation. European Group for the Study of Insulin Resistance (EGIR). Diabet Med. 1999 May;16(5):442-3. doi: 10.1046/j.1464-5491.1999.00059.x. No abstract available.</citation>
    <PMID>10342346</PMID>
  </reference>
  <reference>
    <citation>National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.</citation>
    <PMID>12485966</PMID>
  </reference>
  <reference>
    <citation>Ridker PM, Wilson PW, Grundy SM. Should C-reactive protein be added to metabolic syndrome and to assessment of global cardiovascular risk? Circulation. 2004 Jun 15;109(23):2818-25. doi: 10.1161/01.CIR.0000132467.45278.59.</citation>
    <PMID>15197153</PMID>
  </reference>
  <reference>
    <citation>Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. doi: 10.1161/CIRCULATIONAHA.106.652859. No abstract available.</citation>
    <PMID>17353456</PMID>
  </reference>
  <reference>
    <citation>Prieto D, Contreras C, Sanchez A. Endothelial dysfunction, obesity and insulin resistance. Curr Vasc Pharmacol. 2014 May;12(3):412-26. doi: 10.2174/1570161112666140423221008.</citation>
    <PMID>24846231</PMID>
  </reference>
  <reference>
    <citation>Anderson TJ. Nitric oxide, atherosclerosis and the clinical relevance of endothelial dysfunction. Heart Fail Rev. 2003 Jan;8(1):71-86. doi: 10.1023/a:1022199021949.</citation>
    <PMID>12652161</PMID>
  </reference>
  <reference>
    <citation>Forconi S, Battistini N, Guerrini M, Passero SG for the SIAM Group. A randomized, ASA-controlled trial of mesoglycan in secondary prevention after cerebral ischemic events. Cerebrovasc Dis 1995; 5:334-341.</citation>
  </reference>
  <reference>
    <citation>Orefice G, Brancaccio V, Coppola G et al. Comparative effects of mesoglycan and ticlopidine treatment on some coagulative parameters in patients with previous ischemic stroke: results of a randomized controlled trial. Current Therapeutic Research 2002; 63:337-343.</citation>
  </reference>
  <reference>
    <citation>Nenci GG, Gresele P, Ferrari G, Santoro L, Gianese F; Mesoglycan Intermittent Claudication Group. Treatment of intermittent claudication with mesoglycan--a placebo-controlled, double-blind study. Thromb Haemost. 2001 Nov;86(5):1181-7.</citation>
    <PMID>11816704</PMID>
  </reference>
  <reference>
    <citation>Charakida M, Masi S, Luscher TF, Kastelein JJ, Deanfield JE. Assessment of atherosclerosis: the role of flow-mediated dilatation. Eur Heart J. 2010 Dec;31(23):2854-61. doi: 10.1093/eurheartj/ehq340. Epub 2010 Sep 23.</citation>
    <PMID>20864485</PMID>
  </reference>
  <reference>
    <citation>Tufano A, Arturo C, Cimino E, Di Minno MN, Di Capua M, Cerbone AM, Di Minno G. Mesoglycan: clinical evidences for use in vascular diseases. Int J Vasc Med. 2010;2010:390643. doi: 10.1155/2010/390643. Epub 2010 Aug 31.</citation>
    <PMID>21152191</PMID>
  </reference>
  <reference>
    <citation>Juhan-Vague I, Morange PE, Alessi MC. The insulin resistance syndrome: implications for thrombosis and cardiovascular disease. Pathophysiol Haemost Thromb. 2002 Sep-Dec;32(5-6):269-73. doi: 10.1159/000073579.</citation>
    <PMID>13679655</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Ugo Oliviero</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Mesoglycan</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Flow Mediated Dilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02254850
org study id: Mesoglicano 29/13
nct id: NCT02254850
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Improvement of FMD
time frame: 90 days
description: Verify if taken chronically mesoglycan 1 cp morning and evening for 90 days change compared to placebo vascular reactivity in subjects with metabolic syndrome (increased FMD in the treated group compared to baseline after 90 days of therapy) .
measure: Improvement of FMD
time frame: 2 and 6 hours
description: Verify if the mesoglycan administered intramuscularly change the vascular reactivity compared to placebo in subjects with metabolic syndrome (increased FMD from baseline in 2 and 6 hours after intramuscular administration)
arm group label: Mesoglycan
arm group type: Experimental
description: The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml and inactive ingredients: sodium chloride, chlorocresol, water for injections.
Nextly the patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing: Mesoglycan 50 mg and Inactive ingredients: lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, erythrosine.
Patients also performed Flow Mediated Dilation (FMD).
arm group label: Placebo
arm group type: Placebo Comparator
description: The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.
Nextly 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.
Patients also performed Flow Mediated Dilation (FMD).
intervention type: Procedure
intervention name: Flow Mediated Dilation
description: 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.
arm group label: Mesoglycan
arm group label: Placebo
other name: FMD
intervention type: Drug
intervention name: Mesoglycan
description: The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml.
arm group label: Mesoglycan
other name: Mesoglycan Intramuscular injecion
intervention type: Drug
intervention name: Mesoglycan
description: The patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing: Mesoglycan 50 mg.
arm group label: Mesoglycan
other name: Mesoglycan Oral Treatment
intervention type: Drug
intervention name: Placebo
description: The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.
arm group label: Placebo
other name: Placebo Intramuscular Injection
intervention type: Drug
intervention name: Placebo
description: 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.
arm group label: Placebo
other name: Placebo Oral Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ugo Oliviero, MD
role: Principal Investigator
affiliation: Federico II University-Dipartimento di Scienze Mediche Traslazionali
facility: 
country: Italy
citation: Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available. Erratum In: Circulation. 2005 Oct 25;112(17):e297. Circulation. 2005 Oct 25;112(17):e298.
PMID: 16157765
citation: Reaven G. The metabolic syndrome or the insulin resistance syndrome? Different names, different concepts, and different goals. Endocrinol Metab Clin North Am. 2004 Jun;33(2):283-303. doi: 10.1016/j.ecl.2004.03.002.
PMID: 15158520
citation: Balkau B, Charles MA. Comment on the provisional report from the WHO consultation. European Group for the Study of Insulin Resistance (EGIR). Diabet Med. 1999 May;16(5):442-3. doi: 10.1046/j.1464-5491.1999.00059.x. No abstract available.
PMID: 10342346
citation: National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
PMID: 12485966
citation: Ridker PM, Wilson PW, Grundy SM. Should C-reactive protein be added to metabolic syndrome and to assessment of global cardiovascular risk? Circulation. 2004 Jun 15;109(23):2818-25. doi: 10.1161/01.CIR.0000132467.45278.59.
PMID: 15197153
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responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Ugo Oliviero
investigator title: Medical Doctor
mesh term: Metabolic Syndrome
mesh term: Syndrome