NCT00982670

Brief Summary

An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

September 22, 2009

Last Update Submit

September 22, 2009

Conditions

Metabolic SyndromeCardiovascular Risk FactorsSystemic Lupus Erythematosus

Keywords

Metabolic syndromeSystemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

  • The prevalence of the metabolic syndrome in patients with systemic lupus erythematosus in Taiwan

    One year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons aged 18 and above.

You may qualify if:

  • 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.

You may not qualify if:

  • Exclude a history myocardial infarction, angina or stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Pan-Chiao, Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stored serum

MeSH Terms

Conditions

Metabolic SyndromeLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Chun-Chen Yang, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations

TW(1)