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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)

NCT02338999

Systemic Lupus Erythematosus

COMPLETED PHASE1/PHASE2

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

NCT00739050

Systemic Lupus Erythematosus

TERMINATED PHASE4

Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

NCT01405196

Lupus Erythematosus, Systemic

COMPLETED PHASE2

Low-dose IL-2( Interleukin-2) Treatment in SLE

NCT02084238

Systemic Lupus Erythematosus

COMPLETED NA

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

NCT01196091

Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sugar pill

tablet similar to comparator

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablet taken once a day

pioglitazone

30 mg tablets QD (taken once daily)

Group Type ACTIVE_COMPARATOR

pioglitazone

Intervention Type DRUG

30 mg tablet QD (taken once daily)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pioglitazone

30 mg tablet QD (taken once daily)

Intervention Type DRUG

placebo

tablet taken once a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

actos zactos

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No