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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322308
• Other study ID #: 05-487
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2011
• Last updated: September 30, 2014
• Start date: March 2007
• Est. completion date: January 2012

Study information

• Verified date: September 2014
• Source: National Heart Institute, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• pioglitazone
30 mg tablet QD (taken once daily)
• placebo
tablet taken once a day

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Heart Institute, Mexico	National Council of Science and Technology, Mexico, Universidad Nacional Autonoma de Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of endothelial function	Basal and final (12 weeks) endothelial function parameters measured by PET scan	12 weeks	No
Secondary	change in HDL particle physicochemical characteristics	HDL particle size, distribution and composition evaluated at baseline and at 12 weeks	12 weeks	No