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Regional Observation of the Metabolic Syndrome (ORSA)

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ClinicalTrials.gov Identifier: NCT00874952
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : February 17, 2010
Information provided by:

Brief Summary:
The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a regional basis, defined according to National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPIII) guidelines criteria.

Condition or disease
Metabolic Syndrome

Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Regional Observation of the Metabolic Syndrome
Study Start Date : March 2009
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Prevalence of metabolic syndrome in primary care population [ Time Frame: At visit ]
  2. Concomitant presence of other cardiovascular (CV) risk factors. [ Time Frame: At visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

  • Signed informed consent
  • Laboratory analysis (lipidic profile and glycemia) performed in the last year

Exclusion Criteria:

  • 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
  • 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

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): NCT00874952

Research Site
Torino, Italy
Sponsors and Collaborators
Study Chair: Mario Mangrella AstraZeneca S.p.A.
Study Director: Raffaele Sabia AstraZeneca S.p.A.

Responsible Party: Raffaele Sabia/MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00874952     History of Changes
Other Study ID Numbers: NIS-CIT-DUM-2007/1
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

Keywords provided by AstraZeneca:
Metabolic syndrome
Waist Circumference

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