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Regional Observation of the Metabolic Syndrome (ORSA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874952
First Posted: April 3, 2009
Last Update Posted: February 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Regional Observation of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 1600
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

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
  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): NCT00874952


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

Responsible Party: Raffaele Sabia/MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00874952     History of Changes
Other Study ID Numbers: NIS-CIT-DUM-2007/1
First Submitted: April 2, 2009
First Posted: April 3, 2009
Last Update Posted: February 17, 2010
Last Verified: February 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