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Metabolic Syndrome Observation on a Regional Basis (ORSA Umbria)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00933010
First received: July 2, 2009
Last updated: October 12, 2010
Last verified: October 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 NCEP/ATPIII Guidelines criteria.


Condition
Metabolic Syndrome

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

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: 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 ]

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

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: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00933010     History of Changes
Other Study ID Numbers: NIS-CIT-DUM-2008/1
Study First Received: July 2, 2009
Last Updated: October 12, 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 16, 2013