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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014