Insulin Resistance and Atherosclerosis in Women With Lupus
NCT ID: NCT00544102
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2007-10-11
2017-09-07
Brief Summary
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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.
Detailed Description
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The combination of atherosclerosis and lupus greatly increases the risk of cardiovascular disease among women. Research has identified many factors that contribute to the risk of atherosclerosis in people with lupus. These include high blood pressure and abnormal cholesterol levels, chronic inflammation, antibodies that attack proteins that regulate the blood vessels, and some medications used to treat lupus.
In the general population, diabetes is an important risk factor for atherosclerosis. A silent condition called insulin resistance can lead to diabetes and has been associated with atherosclerosis in populations that do not have lupus. Recent studies have shown people with lupus are more likely to have insulin resistance than those without the disease.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Must give written informed consent prior to entry in the protocol.
* Must fulfill at least 4 of the classification criteria for SLE as defined by the American College of Rheumatology.
* Diagnosis of SLE made 5 or more years prior to study participation.
Exclusion Criteria
* Previous diagnosis of Type 1 or 2 diabetes mellitus.
* History of cerebrovascular accident (CVA: presence of irreversible or partially reversible motor and/or sensory deficits of sudden or recent onset on the basis of vascular occlusion or insufficiency, complete, incomplete or in evolution, persisting greater than 24 hours or lasting less than 24 hours with an anatomic correlate).
* Previous diagnosis of peripheral vascular disease (PVD: presence of arterial claudication \[pain in the muscles of the upper or lower extremities, induced by exercise and relieved by rest, with absent pulses and/or confirmed by Doppler flow studies and/or angiography\] lasting greater than 6 months and/or evidence of gangrene or significant tissue (digit or limb) loss not attributable to Raynaud s phenomenon).
* Therapy with pulse methylprednisolone or pulse prednisone within 4 weeks of study participation.
* Initiation or change in dosage of antilipemic agents within the preceding six weeks.
* Any active viral or bacterial infection
* Significant concurrent medical condition that, in the opinion of the Principal Investigator, could affect the patient s ability to tolerate or complete the study.
* Clinical coronary artery disease (CAD) defined as: history of MI and/or definite or classic angina (substernal chest discomfort provoked by exertion or emotion and relieved by rest or nitroglycerine), and/or conclusive evidence of MI on ECG
* Renal failure defined as hemodialysis-dependant, or calculated GFR less than or equal to 30 mL/minute (calculated by the MDRD 4 variable formula).
30 Years
55 Years
FEMALE
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Responsible Party
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Principal Investigators
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Sarfaraz A Hasni, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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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.
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.
Other Identifiers
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08-AR-0008
Identifier Type: -
Identifier Source: secondary_id
080008
Identifier Type: -
Identifier Source: org_study_id