Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- placebo
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- National Heart Institute, Mexico
- Enrollment
- 30
- Primary Endpoint
- improvement of endothelial function
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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).
Investigators
Nacu Caracas Portilla
Juan Gabriel Juarez Rojas PhD
National Heart Institute, Mexico
Eligibility Criteria
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
- •thyroid dysfunction
- •neurological
- •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
Arms & Interventions
sugar pill
tablet similar to comparator
Intervention: placebo
pioglitazone
30 mg tablets QD (taken once daily)
Intervention: pioglitazone
Outcomes
Primary Outcomes
improvement of endothelial function
Time Frame: 12 weeks
Basal and final (12 weeks) endothelial function parameters measured by PET scan
Secondary Outcomes
- change in HDL particle physicochemical characteristics(12 weeks)