Regional Observation of the Metabolic Syndrome | NCT00874952

Studies
Regional Observation of the Metabolic Syndrome

NCT00874952

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Feb 17, 2010Estimated

Enrollment

1,600Estimated

Phase

Not provided

Conditions

Metabolic Syndrome

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Apr 2, 2009

First Submission Date that Met QC Criteria

Apr 2, 2009

First Posted Date

Apr 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2010

Last Update Posted Date

Feb 17, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of metabolic syndrome in primary care population		At visit
Concomitant presence of other cardiovascular (CV) risk factors.		At visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mario Mangrella	AstraZeneca S.p.A.	Study Chair
Raffaele Sabia	AstraZeneca S.p.A.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Torino			Italy

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D006973	Hypertension

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided