Mesoglycan, Vascular Reactivity and Metabolic Syndrome

NCT02254850 | Completed Phase 4

• 1 other identifier: Mesoglicano 29/13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Metabolic Syndrome

Keywords

Mesoglycan; Metabolic Syndrome; Flow Mediated Dilation

Outcome Measures

Primary Outcomes (1)

• Improvement of FMD

  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 Outcomes (1)

• Improvement of FMD

  2 and 6 hours

Study Arms (2)

Mesoglycan

EXPERIMENTAL

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; Drug: Mesoglycan

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

Flow Mediated Dilation PROCEDURE

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.

Also known as: FMD

Mesoglycan; Placebo

Mesoglycan DRUG

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

Also known as: Mesoglycan Intramuscular injecion

Mesoglycan

Placebo DRUG

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

Also known as: Placebo Intramuscular Injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Ugo Oliviero

Via Pansini, 5, Napoli, 80131, Italy

Location

Related Publications (14)

• 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.

  PMID: 16157765 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 17353456 BACKGROUND

• 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.

  PMID: 24846231 BACKGROUND

• 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.

  PMID: 12652161 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11816704 BACKGROUND

• 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.

  PMID: 20864485 BACKGROUND

• 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.

  PMID: 21152191 BACKGROUND

• 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.

  PMID: 13679655 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

mesoglycan

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ugo Oliviero, MD

  Federico II University-Dipartimento di Scienze Mediche Traslazionali

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 2, 2014
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-09

Locations

IT (1)