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A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982670
First Posted: September 23, 2009
Last Update Posted: September 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Far Eastern Memorial Hospital
  Purpose
An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.

Condition
Metabolic Syndrome Cardiovascular Risk Factors Systemic Lupus Erythematosus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association of the Metabolic Syndrome and Systemic Lupus Erythematosus in Taiwan

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • The prevalence of the metabolic syndrome in patients with systemic lupus erythematosus in Taiwan [ Time Frame: One year ]

Biospecimen Retention:   Samples Without DNA
Stored serum

Enrollment: 100
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Persons aged 18 and above.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclude a history myocardial infarction, angina or stroke.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982670


Locations
Taiwan
Far Eastern Memorial Hospital
Pan-Chiao, Taipei, Taiwan
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Chun-Chen Yang, MD Far Eastern Memorial Hospital
  More Information

Responsible Party: Chun-Chen Yang, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00982670     History of Changes
Other Study ID Numbers: FEMH-96-D-032
First Submitted: September 22, 2009
First Posted: September 23, 2009
Last Update Posted: September 23, 2009
Last Verified: September 2009

Keywords provided by Far Eastern Memorial Hospital:
Metabolic syndrome
Systemic lupus erythematosus

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Lupus Erythematosus, Systemic
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases