NCT00544102

Insulin Resistance and Atherosclerosis in Women With Lupus

Completed Last updated 17 December 2019

What this trial tests

trial in Systemic Lupus Erythematosus in 50 participants. Completed in 7 September 2017.

Timeline

11 October 2007

7 September 2017

Quick facts

Lead sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	11 October 2007
Estimated completion	7 September 2017
Sites	1 location across United States

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
• Insulin Resistance — all drugs for Insulin Resistance →
• Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

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

Who can join

Adults 30 to 55, female only, with Systemic Lupus Erythematosus or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.