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Insulin Resistance and Atherosclerosis in a Sample of Women with Systemic Lupus Erythematosus
This study is NOT currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
08-AR-0008 |
Sponsoring Institute |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing |
Referral Letter Required |
No |
Population Exclusion(s) |
Male; |
Special Instructions |
Currently Not Provided |
Keywords |
Insulin Resistance; |
Recruitment Keyword(s) |
Systemic Lupus Erythematosus; |
Condition(s) |
Systemic Lupus Erythematosus; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
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.
Eligibility
INCLUSION CRITERIA:
-Women 30-55 years of age.
-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:
-Pregnancy within one year of study participation. Women of childbearing potential are required to have a negative pregnancy test at screening.
-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).
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Gabor G. Illei, M.D. National Institute of Dental And Craniofacial Research (NIDCR) National Institutes of Health Building 10 Room 1N110 10 Center Drive Bethesda, Maryland 20892 (301) 496-1363 illeig@exchange.nih.gov |
Donna F. Hardwick, R.N. National Institute of Dental And Craniofacial Research (NIDCR) National Institutes of Health Building 10 Room 6N226 10 Center Drive Bethesda, Maryland 20892 (301) 402-6409 dhardwick@mail.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00544102
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