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Metabolic Syndrome Observation on a Regional Basis (ORSA Umbria)

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ClinicalTrials.gov Identifier: NCT00933010
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Metabolic Syndrome

Study Design

Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Osservatorio Regionale Sulla Sindrome metabolicA
Study Start Date : October 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of Metabolic Syndrome in Primary Care Population [ Time Frame: July 2009 - March 2010 ]
  2. Concomitant presence of other CV risk factors [ Time Frame: July 2009 - March 2010 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933010


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

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00933010     History of Changes
Other Study ID Numbers: NIS-CIT-DUM-2008/1
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

Keywords provided by AstraZeneca:
metabolic syndrome
lipids
waist circumference
HDL
hypertension

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases