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Regional Observatory on Metabolic Syndrome- LAZIO (ORSA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689455
First Posted: June 3, 2008
Last Update Posted: December 3, 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: Time Perspective: Cross-Sectional
Official Title: Regional Observatory on Metabolic Syndrome in Italy- LAZIO

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 ]

Secondary Outcome Measures:
  • Concomitant presence of other CV risk factors. [ Time Frame: At Visit ]

Enrollment: 1574
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Primary care population

  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:

  • lipid profile in the last year
  • Signed informed consent

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
  • Subject who are unwilling or unable to provide the informed consent
  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): NCT00689455


Locations
Italy
Research Site
Rieti, Italy
Research Site
ROme, Italy
Research Site
Viterbo, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Volpe Massimo, MD, FACC Cardiology Dept. Director, Sapienza University, Sant' Andrea Hospital, Rome
  More Information

Responsible Party: Mario Mangrella MD Medical Manager, Cardiometabolic Team, AstraZeneca S.p.A.
ClinicalTrials.gov Identifier: NCT00689455     History of Changes
Other Study ID Numbers: NIS-CIT-DUM-2008/2
First Submitted: May 29, 2008
First Posted: June 3, 2008
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Metabolic Syndrome
Lipids
Waist Circumference

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