Metabolic SyndromeORSA UmbriaNCT00933010
Metabolic Syndrome Observation on a Regional Basis
An observational study of Metabolic Syndrome, run by AstraZeneca at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 1,600 participants
- Where
- 3 sitesItaly
- Study dates
- Oct 2009to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patient aged between 18 and 75 years
- Signed Informed consent
- Laboratory analysis (lipidic profile and glycemia) performed in the last year
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Osservatorio Regionale Sulla Sindrome metabolicA
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.
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, lipids, waist circumference, HDL, hypertension
- Medical subject headings
- Metabolic Syndrome, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Metabolic Syndrome in Primary Care Population
Measured: July 2009 - March 2010
Concomitant presence of other CV risk factors
Measured: July 2009 - March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mario Mangrella, Study chair, AstraZeneca S.p.A., R&DRaffaele Sabia, Study director, AstraZeneca S.p.A., R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933010
- Sponsor's protocol ID
- NIS-CIT-DUM-2008/1
- Acronym
- ORSA Umbria
- Status last verified
- Oct 2010
- First submitted
- 2 Jul 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osservatorio Regionale Sulla Sindrome metabolicA
- ClinicalTrials.gov ID
- NCT00933010
- Acronym / sponsor ID
- ORSA Umbria / NIS-CIT-DUM-2008/1
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, lipids, waist circumference, HDL, hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Patient aged between 18 and 75 years
- Signed Informed consent
- Laboratory analysis (lipidic profile and glycemia) performed in the last year
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Metabolic Syndrome in Primary Care Population
Time frame: July 2009 - March 2010
Concomitant presence of other CV risk factors
Time frame: July 2009 - March 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Mangrella study chair
AstraZeneca S.p.A., R&D
Raffaele Sabia study director
AstraZeneca S.p.A., R&D
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by AstraZeneca at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Metabolic Syndrome in Primary Care Population (time frame: July 2009 - March 2010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.