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

This study has been completed.
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00982670
First received: September 22, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chun-Chen Yang, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00982670     History of Changes
Other Study ID Numbers: FEMH-96-D-032
Study First Received: September 22, 2009
Last Updated: September 22, 2009
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013