Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial|
- improvement of endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Basal and final (12 weeks) endothelial function parameters measured by PET scan
- change in HDL particle physicochemical characteristics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]HDL particle size, distribution and composition evaluated at baseline and at 12 weeks
|Study Start Date:||March 2007|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: sugar pill
tablet similar to comparator
tablet taken once a day
Active Comparator: pioglitazone
30 mg tablets QD (taken once daily)
30 mg tablet QD (taken once daily)
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322308
|Study Chair:||Carlos Posadas, MD||Head of the Endocrinology Department|