Protocol Number: 08-AR-0008

Title:

Insulin Resistance and Atherosclerosis in a Sample of Women with Systemic Lupus Erythematosus

Number:

08-AR-0008

Summary:

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:

-Blood and urine tests for research purposes.

-Electrocardiogram (EKG) to test the general health of the heart.

-Oral glucose tolerance test to measure blood glucose and insulin levels. This test is commonly used to diagnose diabetes and pre-diabetic insulin resistance.

-Cardiac multidetector computed tomography (MDCT) to determine the amount of calcium present in coronary arteries. This test is used to diagnose atherosclerosis.

-Carotid artery ultrasound to show the speed of blood flow through the carotid arteries. This test will show abnormalities and/or blockages in the carotid arteries.

-Abdominal ultrasound to determine if the participant has hepatic steatosis ( fatty liver ), which is often found in individuals with insulin resistance and diabetes.

-Carotid artery magnetic resonance imaging/angiogram (MRI/MRA) to measure the thickness of blood vessels. This test is used to diagnose atherosclerosis.

-Abdominal MRI to estimate abdominal fat.

Volunteers may be asked to participate in an MRI/MRA study to evaluate the arteries of the heart. This test is optional and not required by the insulin resistance/atherosclerosis study. The entire series of procedures will require one to three visits to complete.

Sponsoring Institute:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Insulin Resistance

Systemic Lupus Erythematosus

Atherosclerosis

Women

Glucose Intolerance

Recruitment Keyword(s):

Systemic Lupus Erythematosus

Lupus

SLE

Insulin Resistance

Atherosclerosis

Condition(s):

Systemic Lupus Erythematosus

Insulin Resistance

Atherosclerosis

Abnormal Glucose Metabolism

Cardiac Risk Factors

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

None

Supporting Site:

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

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.

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.

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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