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NCT Number: NCT01322308

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

30 mg tablet QD (taken once daily)

Other names: actos, zactos

Placebo

Drug

tablet taken once a day

Primary outcomes

  1. improvement of endothelial function

    Time frame: 12 weeks

    Basal and final (12 weeks) endothelial function parameters measured by PET scan

Secondary outcomes

  1. change in HDL particle physicochemical characteristics

    Time frame: 12 weeks

    HDL particle size, distribution and composition evaluated at baseline and at 12 weeks

Sponsors and collaborators

Lead sponsor

National Heart Institute, Mexico

Other Gov

Collaborators

  • National Council of Science and Technology, Mexico
  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 24, 2011
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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