NCT00933010

Brief Summary

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.

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 Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

July 2, 2009

Last Update Submit

October 12, 2010

Conditions

Metabolic Syndrome

Keywords

metabolic syndromelipidswaist circumferenceHDLhypertension

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Metabolic Syndrome in Primary Care Population

    July 2009 - March 2010

  • Concomitant presence of other CV risk factors

    July 2009 - March 2010

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Patient aged between 18 and 75 years
  • Signed Informed consent
  • Laboratory analysis (lipidic profile and glycemia) performed in the last year

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research

Foligno, Italy

Location

Research Site

Perugia, Italy

Location

Research Site

Terni, 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., R&D

    STUDY CHAIR

  • Raffaele Sabia

    AstraZeneca S.p.A., R&D

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

IT(3)