NCT00874952

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

11 months

First QC Date

April 2, 2009

Last Update Submit

February 16, 2010

Conditions

Metabolic Syndrome

Keywords

Metabolic syndromeLipidsWaist CircumferenceHDLhypertension

Outcome Measures

Primary Outcomes (2)

  • Prevalence of metabolic syndrome in primary care population

    At visit

  • Concomitant presence of other cardiovascular (CV) risk factors.

    At visit

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Torino, Italy

Location

MeSH Terms

Conditions

Metabolic SyndromeHypertension

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mario Mangrella

    AstraZeneca S.p.A.

    STUDY CHAIR

  • Raffaele Sabia

    AstraZeneca S.p.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

IT(1)