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Sponsor study identifier
Secondary identifiers
observational
50
1 country
1
Study Start
October 11, 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 7, 2017
Date type not reportedThis date has not been verified as actual or estimated.
This study will test the effects of insulin resistance on atherosclerosis (hardening of the arteries) in women who have systemic lupus erythematosus, more commonly known as lupus. Women with lupus have a higher chance of developing atherosclerosis than the general population, and as a result are more susceptible to heart attack and stroke. Insulin resistance is a particular risk factor for atherosclerosis, and recent small studies have shown that insulin resistance is more common in lupus patients than in those without lupus. The study will consist of a series of tests designed to assess whether there is an association between insulin resistance and atherosclerosis in women with lupus. This research may lead to further studies on possible treatments to reduce the risk of heart disease in lupus patients. Volunteers must be women between 30 and 55 years of age who were diagnosed with lupus within five or more years prior to the study. Volunteers who have kidney failure, diabetes, or existing atherosclerosis will be excluded from the study, as will volunteers who have had pulse steroid therapy within four weeks of the testing or who have been pregnant within one year of the testing. Participants will undergo the following procedures on an outpatient basis:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 7, 2017
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2007
Actual (reported)October 16, 2007
Actual (reported)September 7, 2017
Date type not reportedThis date has not been verified as actual or estimated.
Correlation of insulin resistance with coronary atherosclerosis
Prevalance of insulin resistance and impaired glucose tolerance in SLE prevalence of atherosclerosis via coronary artery measurements, correlation of insulin resistance and potential bio-markers SHBG and retinal binding protein
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Manzi S, Meilahn EN, Rairie JE, Conte CG, Medsger TA Jr, Jansen-McWilliams L, D'Agostino RB, Kuller LH. Age-specific incidence rates of myocardial infarction and angina in women with systemic lupus erythematosus: comparison with the Framingham Study. Am J Epidemiol. 1997 Mar 1;145(5):408-15. doi: 10.1093/oxfordjournals.aje.a009122.
Doria A, Shoenfeld Y, Wu R, Gambari PF, Puato M, Ghirardello A, Gilburd B, Corbanese S, Patnaik M, Zampieri S, Peter JB, Favaretto E, Iaccarino L, Sherer Y, Todesco S, Pauletto P. Risk factors for subclinical atherosclerosis in a prospective cohort of patients with systemic lupus erythematosus. Ann Rheum Dis. 2003 Nov;62(11):1071-7. doi: 10.1136/ard.62.11.1071.
Sarfaraz A Hasni, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
50 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2007
First Posted
October 16, 2007
Study Start
October 11, 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Bruce IN, Burns RJ, Gladman DD, Urowitz MB. Single photon emission computed tomography dual isotope myocardial perfusion imaging in women with systemic lupus erythematosus. I. Prevalence and distribution of abnormalities. J Rheumatol. 2000 Oct;27(10):2372-7.
Study Completion
September 7, 2017
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
December 17, 2019
Record last verified: 2017-09-07
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Source: ClinicalTrials.gov.
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