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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01322308

Enrollment

Registered

2011-03-24

Start date

2007-03-31

Completion date

2012-01-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

lupus, HDL particles, endothelial function, pioglitazone

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).

Interventions

DRUGpioglitazone

30 mg tablet QD (taken once daily)

DRUGplacebo

tablet taken once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
improvement of endothelial function	12 weeks	Basal and final (12 weeks) endothelial function parameters measured by PET scan

Secondary

Measure	Time frame	Description
change in HDL particle physicochemical characteristics	12 weeks	HDL particle size, distribution and composition evaluated at baseline and at 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026