Mesoglycan, Vascular Reactivity and Metabolic Syndrome

September 30, 2014 updated by: Ugo Oliviero, Federico II University

The Mesoglycan and Vascular Reactivity in the Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Napoli
      • Via Pansini, 5, Napoli, Italy, 80131
        • Ugo Oliviero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesoglycan

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).
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.
Other Names:
  • FMD
Drug: Mesoglycan
The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml.
Other Names:
  • Mesoglycan Intramuscular injecion
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.
Other Names:
  • Mesoglycan Oral Treatment
Placebo Comparator: Placebo

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).
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.
Other Names:
  • FMD
Drug: Placebo
The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.
Other Names:
  • Placebo Intramuscular Injection
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.
Other Names:
  • Placebo Oral Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of FMD
Time Frame: 90 days
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) .
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of FMD
Time Frame: 2 and 6 hours
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)
2 and 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Ugo Oliviero, MD, Federico II University-Dipartimento di Scienze Mediche Traslazionali

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mesoglicano 29/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Syndrome

Clinical Trials on Flow Mediated Dilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe