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Metabolic Syndrome Observation on a Regional Basis (ORSA Umbria)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00933010
First Posted: July 7, 2009
Last Update Posted: October 13, 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 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:


Further study details as provided by AstraZeneca:

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

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

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 Submitted: July 2, 2009
First Posted: July 7, 2009
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