Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT01322308|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : October 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: pioglitazone Drug: placebo||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
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)
- improvement of endothelial function [ Time Frame: 12 weeks ]Basal and final (12 weeks) endothelial function parameters measured by PET scan
- change in HDL particle physicochemical characteristics [ Time Frame: 12 weeks ]HDL particle size, distribution and composition evaluated at baseline and at 12 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322308
|Study Chair:||Carlos Posadas, MD||Head of the Endocrinology Department|