NCT00689455

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
1,574

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

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

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

1.2 years

First QC Date

May 29, 2008

Last Update Submit

December 2, 2010

Conditions

Metabolic Syndrome

Keywords

Metabolic SyndromeLipidsWaist Circumference

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Metabolic Syndrome in Primary Care Population.

    At Visit

Secondary Outcomes (1)

  • Concomitant presence of other CV risk factors.

    At Visit

Study Arms (1)

1

Primary care population

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:

  • lipid profile in the last year
  • Signed informed consent

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
  • Subject who are unwilling or unable to provide the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Rieti, Italy

Location

Research Site

Rome, Italy

Location

Research Site

Viterbo, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Volpe Massimo, MD, FACC

    Cardiology Dept. Director, Sapienza University, Sant' Andrea Hospital, Rome

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 3, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

IT(3)