Systemic Lupus ErythematosusNCT00544102
Insulin Resistance and Atherosclerosis in Women With Lupus
An observational study of Systemic Lupus Erythematosus and Insulin Resistance, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Insulin Resistance, Atherosclerosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2007to 7 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Insulin Resistance and Atherosclerosis in a Sample of Women With Systemic Lupus Erythematosus
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.
Read more
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.
Read the detailed description
Women with lupus have a five- to ten-fold increased risk of coronary heart disease compared to the general population. Several decades ago, when women with lupus died shortly after developing the disease, their deaths were attributed to previously undiagnosed and untreated active lupus. But when they died years after their diagnosis of lupus, their deaths were attributed to complications of atherosclerosis (hardening of the arteries). Similar to lupus, atherosclerosis is considered an inflammatory disease. Inflammation plays a major role in atherosclerosis, which results when fatty deposits, cholesterol and other materials accumulate in the blood vessels.
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.
- Keywords
- Insulin Resistance, Systemic Lupus Erythematosus, Atherosclerosis, Lupus, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic, Insulin Resistance, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of insulin resistance with coronary atherosclerosis
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study start11 Oct 2007
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sarfaraz A Hasni, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544102
- Sponsor's protocol ID
- 080008
- Other IDs
- 08-AR-0008
- Status last verified
- 7 Sep 2017
- First submitted
- 14 Oct 2007
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
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.
PubMed 9048514Doria 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.
PubMed 14583570Bruce 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.
PubMed 11036832
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Atherosclerosis in a Sample of Women With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00544102
- Acronym / sponsor ID
- 080008
- Keywords
- Insulin Resistance, Systemic Lupus Erythematosus, Atherosclerosis, Lupus, SLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 11 Oct 2007
- Study completion
- 7 Sep 2017
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women with lupus have a five- to ten-fold increased risk of coronary heart disease compared to the general population. Several decades ago, when women with lupus died shortly after developing the disease, their deaths were attributed to previously undiagnosed and untreated active lupus. But when they died years after their diagnosis of lupus, their deaths were attributed to complications of atherosclerosis (hardening of the arteries). Similar to lupus, atherosclerosis is considered an inflammatory disease. Inflammation plays a major role in atherosclerosis, which results when fatty deposits, cholesterol and other materials accumulate in the blood vessels.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of insulin resistance with coronary atherosclerosis
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 9048514Manzi 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.
- Background: PubMed 14583570Doria 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.
- Background: PubMed 11036832Bruce 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarfaraz A Hasni, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Insulin Resistance, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of insulin resistance with coronary atherosclerosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00544102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.