Regional Observation of the Metabolic Syndrome (ORSA)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00874952
First received: April 2, 2009
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a regional basis, defined according to National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPIII) guidelines criteria.


Condition
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Regional Observation of the Metabolic Syndrome

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 ] [ Designated as safety issue: No ]
  • Concomitant presence of other cardiovascular (CV) risk factors. [ Time Frame: At visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Signed informed consent
  • Laboratory analysis (lipidic profile and glycemia) performed in the last year

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
  • Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs
  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: NCT00874952

Locations
Italy
Research Site
Torino, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Mario Mangrella AstraZeneca S.p.A.
Study Director: Raffaele Sabia AstraZeneca S.p.A.
  More Information

No publications provided

Responsible Party: Raffaele Sabia/MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00874952     History of Changes
Other Study ID Numbers: NIS-CIT-DUM-2007/1
Study First Received: April 2, 2009
Last Updated: February 16, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
Metabolic syndrome
Lipids
Waist Circumference
HDL
hypertension

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

ClinicalTrials.gov processed this record on October 19, 2014