Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus
- Registration Number
- NCT01322308
- Lead Sponsor
- National Heart Institute, Mexico
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- Eligible participants were premenopausal women with SLE
- Older than 18 years
- Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary care hospitals
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sugar pill placebo tablet similar to comparator pioglitazone pioglitazone 30 mg tablets QD (taken once daily)
- Primary Outcome Measures
Name Time Method improvement of endothelial function 12 weeks Basal and final (12 weeks) endothelial function parameters measured by PET scan
- Secondary Outcome Measures
Name Time Method change in HDL particle physicochemical characteristics 12 weeks HDL particle size, distribution and composition evaluated at baseline and at 12 weeks