Metabolic SyndromeNCT02379702
Metabolic Syndrome Prevalence Study
An observational study of Metabolic Syndrome, run by Abdi Ibrahim Ilac San. ve Tic A.S. at 6 sites in Turkey (Türkiye).
Trial summary
Following the first study conducted to investigate the prevalence of metabolic syndrome and its components in Turkey, it was aimed to demonstrate the change in general health condition of available patients after the period of time lapsed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Metabolic Syndrome
- How many people
- 1,659 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- Jun 2014to Nov 2014
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The previous study included 4.264 patients from 47 cities and we are going to try to get in contact all those patients. Data obtained from available patients will be analysed and the change trend will be evaluated
Who may be able to join
- Volunteers who participated in the METSAR-I study in 2003
- Patients who accepted to participate will be included the second follow up phase.
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Ankara University
Ankara
Gazi University
Ankara
Yuksek Ihtisas Hospital
Ankara
Istanbul Cerrahpasa University
Istanbul
Istanbul Medeniyet University
Istanbul
Prof. Dr. Omer Kozan
Izmir
About this study
Official title: Turkey Metabolic Syndrome Prevalence Study - METSAR II
Following the first study conducted to investigate the prevalence of metabolic syndrome and its components in Turkey, it was aimed to demonstrate the change in general health condition of available patients after the period of time lapsed. This study will provide important information on the social and economic dimensions of metabolic syndrome and will contribute to development of preventive programs.
Read the detailed description
In the first METSAR-I study conducted in 2003, metabolic syndrome screening was made by two different team. Participants were visited at their addresses and informed about the research study and gave written consent. They were invited on an empty stomach for hospital visit on the day after. Pre-trained nurses completed the forms of patients during that second visit. After 11 years, a questionnaire by telephone survey will be applied to patients who participated in the METSAR-II study. The main goal is to determine the changes of metabolic syndrome population during that period.
- Conditions
- Metabolic Syndrome
- Being tested
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic SyndromeOther
This study will provide important information on the social and economic dimensions of metabolic syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
comorbidities and changes in general health
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
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.
- 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
- Time perspective
- Prospective
- Enrolment
- 1,659 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Abdi Ibrahim Ilac San. ve Tic A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omer Kozan, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379702
- Sponsor's protocol ID
- METSAR-II
- Status last verified
- Mar 2015
- First submitted
- 17 Oct 2014
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkey Metabolic Syndrome Prevalence Study - METSAR II
- ClinicalTrials.gov ID
- NCT02379702
- Acronym / sponsor ID
- METSAR-II
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,659 participants (actual)
- Lead sponsor
- Abdi Ibrahim Ilac San. ve Tic A.S.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Mar 2015 (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.
Following the first study conducted to investigate the prevalence of metabolic syndrome and its components in Turkey, it was aimed to demonstrate the change in general health condition of available patients after the period of time lapsed. This study will provide important information on the social and economic dimensions of metabolic syndrome and will contribute to development of preventive programs.
Detailed description
In the first METSAR-I study conducted in 2003, metabolic syndrome screening was made by two different team. Participants were visited at their addresses and informed about the research study and gave written consent. They were invited on an empty stomach for hospital visit on the day after. Pre-trained nurses completed the forms of patients during that second visit. After 11 years, a questionnaire by telephone survey will be applied to patients who participated in the METSAR-II study. The main goal is to determine the changes of metabolic syndrome population during that period.
Study design
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The previous study included 4.264 patients from 47 cities and we are going to try to get in contact all those patients. Data obtained from available patients will be analysed and the change trend will be evaluated
Key inclusion criteria (2 listed)
- Volunteers who participated in the METSAR-I study in 2003
- Patients who accepted to participate will be included the second follow up phase.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic SyndromeThis study will provide important information on the social and economic dimensions of metabolic syndrome | Other | – |
Primary outcome
comorbidities and changes in general health
Time frame: 10 year
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 5 Mar 2015.
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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.
Omer Kozan study director
Dokuz Eylul University
6 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 Abdi Ibrahim Ilac San. ve Tic A.S. at 6 sites in Turkey (Türkiye).
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 2 inclusion and 1 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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?
comorbidities and changes in general health (time frame: 10 year). 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 5 Mar 2015.