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Regional Observation of the Metabolic Syndrome (ORSA)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00874952
First received: April 2, 2009
Last updated: February 16, 2010
Last verified: February 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Prevalence of metabolic syndrome in primary care population [ Time Frame: At visit ] [ Designated as safety issue: No ]
  • Concomitant presence of other cardiovascular (CV) risk factors. [ Time Frame: At visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Raffaele Sabia/MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00874952     History of Changes
Other Study ID Numbers: NIS-CIT-DUM-2007/1
Study First Received: April 2, 2009
Last Updated: February 16, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
Metabolic syndrome
Lipids
Waist Circumference
HDL
hypertension

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

ClinicalTrials.gov processed this record on May 22, 2013