Metabolic Syndrome Observation on a Regional Basis - Full Text View

Metabolic Syndrome Observation on a Regional Basis (ORSA Umbria)

This study is not yet open for participant recruitment.

Verified by AstraZeneca, July 2009

First Received: July 2, 2009 Last Updated: July 29, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00933010

Purpose

The aim of the study is to assess the prevalence of Metabolic Syndrome in Italy on a regional basis, defined according to NCEP/ATPIII Guidelines criteria.

Condition
Metabolic Syndrome

Study Type:	Observational
Study Design:	Ecologic or Community, Cross-Sectional
Official Title:	Osservatorio Regionale Sulla Sindrome metabolicA

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Prevalence of Metabolic Syndrome in Primary Care Population [ Time Frame: July 2009 - March 2010 ] [ Designated as safety issue: No ]
Concomitant presence of other CV risk factors [ Time Frame: July 2009 - March 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1600
Study Start Date:	July 2009
Estimated Study Completion Date:	March 2010

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

Criteria

Inclusion Criteria:

Patient aged between 18 and 75 years
Signed Informed consent
Laboratory analysis (lipidic profile and glycemia) performed in the last year

Exclusion Criteria:

Pregnancy or breast feeding
Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs
Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933010

Contacts

Contact: AstraZeneca S.p.A. Clinical Study Information

+390298014801

angelo.ferraro@astrazeneca.com

Locations

Italy
Research
Foligno, Italy
Research Site
Perugia, Italy
Research Site
Terni, Italy

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Mario Mangrella	AstraZeneca S.p.A., R&D
Study Director:	Raffaele Sabia	AstraZeneca S.p.A., R&D

More Information

No publications provided

Responsible Party:	AstraZeneca ( MC MD )
Study ID Numbers:	NIS-CIT-DUM-2008/1
Study First Received:	July 2, 2009
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00933010 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by AstraZeneca:

metabolic syndrome
lipids
waist circumference
HDL
hypertension

Study placed in the following topic categories:

Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on September 10, 2009