Regional Observatory on Metabolic Syndrome- LAZIO (ORSA)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689455
First received: May 29, 2008
Last updated: December 2, 2010
Last verified: December 2010
  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

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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 29, 2008
Last Updated: December 2, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
Metabolic Syndrome
Lipids
Waist Circumference

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

ClinicalTrials.gov processed this record on April 16, 2014