Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial function in premenopausal women with SLE (systemic lupus erythematosus). Patients with hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast feeding women. This is a randomized, double blind, placebo controlled study.

Detailed Description
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SLE (systemic lupus erythematosus) is characterized by accelerated atherosclerosis. The risk of suffering an acute myocardial infarction among premenopausal women with SLE is 50 times higher than control women of the same age. Insulin resistance and hyperinsulinemia are frequent in SLE. Lipid metabolism in SLE, as in other insulin resistant states, is characterized by high triglycerides, low HDL-cholesterol, normal LDL cholesterol (or slightly increased) and an increase in LDL's susceptibility to oxidation. All these alterations can produce endothelial dysfunction which is present in SLE patients. Pioglitazone is a PPAR (peroxisome proliferator activated receptor) gamma agonist that can potentially improve insulin resistance, with a positive effect on the lipid profile (lowering of triglycerides, and a discrete increase in HDL-C) and improve endothelial function. Patients will be randomized to receive either placebo or pioglitazone 30 mg/day during a period of 12 weeks. Endothelial function will be assessed by Positron Emission Tomography (PET).

Official Title
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Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: pioglitazone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants were premenopausal women with SLE Older than 18 years Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary care hospitals Exclusion Criteria: menopause diabetes thyroid dysfunction neurological hepatic renal or liver disease personal history of high blood pressure CHD (coronary heart disease) cerebrovascular events chronic or acute infections malignancy nor history of chronic drugs or alcohol abuse smoking pregnancy or breast-feeding intake of hormones or lipid-regulating drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sugar pill<br>tablet similar to comparator | Drug: placebo<br>* tablet taken once a day<br>|
| Active Comparator: pioglitazone<br>30 mg tablets QD (taken once daily) | Drug: pioglitazone<br>* 30 mg tablet QD (taken once daily)<br>* Other names: zactos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of endothelial function | Basal and final (12 weeks) endothelial function parameters measured by PET scan | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in HDL particle physicochemical characteristics | HDL particle size, distribution and composition evaluated at baseline and at 12 weeks | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lupus, HDL particles, endothelial function, pioglitazone