Metabolic SyndromeNCT00982670
A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus
An observational study of Metabolic Syndrome and Cardiovascular Risk Factors, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Cardiovascular Risk Factors, Systemic Lupus Erythematosus
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Jun 2009
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons aged 18 and above.
Who may be able to join
- Persons aged 18 and above.
- Persons fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group.
Who cannot join
- Exclude a history myocardial infarction, angina or stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of the Metabolic Syndrome and Systemic Lupus Erythematosus in Taiwan
An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.
Read the detailed description
This study will investigate the prevalence of the metabolic syndrome in patients with SLE in Taiwan. We expect our study will provide further understanding of the association between SLE and metabolic syndrome, which may give direction to prevent late cardiovascular morbidity and mortality in SLE patients.
- Keywords
- Metabolic syndrome, Systemic lupus erythematosus
- Medical subject headings
- Metabolic Syndrome, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus | Patients should fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus | |
| Normal control | Age- and sex-matched health volunteers will serve as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of the metabolic syndrome in patients with systemic lupus erythematosus in Taiwan
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionJun 2009
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chun-Chen Yang, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982670
- Sponsor's protocol ID
- FEMH-96-D-032
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2009
- Last updated
- 23 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Metabolic Syndrome and Systemic Lupus Erythematosus in Taiwan
- ClinicalTrials.gov ID
- NCT00982670
- Acronym / sponsor ID
- FEMH-96-D-032
- Keywords
- Metabolic syndrome, Systemic lupus erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Sep 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.
An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.
Detailed description
This study will investigate the prevalence of the metabolic syndrome in patients with SLE in Taiwan. We expect our study will provide further understanding of the association between SLE and metabolic syndrome, which may give direction to prevent late cardiovascular morbidity and mortality in SLE patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus | – | –Patients should fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus |
| Normal control | – | –Age- and sex-matched health volunteers will serve as controls. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons aged 18 and above.
Key inclusion criteria (2 listed)
- Persons aged 18 and above.
- Persons fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group.
Key exclusion criteria (1 listed)
- Exclude a history myocardial infarction, angina or stroke.
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
The prevalence of the metabolic syndrome in patients with systemic lupus erythematosus in Taiwan
Time frame: One 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 23 Sep 2009.
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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.
Chun-Chen Yang, MD principal investigator
Far Eastern Memorial Hospital
1 site 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 and Cardiovascular Risk Factors, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The prevalence of the metabolic syndrome in patients with systemic lupus erythematosus in Taiwan (time frame: One 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 23 Sep 2009.