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

This study has been completed.

Sponsor:

Collaborators:

National Council of Science and Technology, Mexico

Universidad Nacional Autonoma de Mexico

Information provided by (Responsible Party):

Nacu Caracas Portilla, National Heart Institute, Mexico

ClinicalTrials.gov Identifier:

NCT01322308

First received: March 23, 2011

Last updated: September 30, 2014

Last verified: September 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: pioglitazone Drug: placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial

Resource links provided by NLM:

Genetics Home Reference related topics: systemic lupus erythematosus

MedlinePlus related topics: Lupus

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Nacu Caracas Portilla, National Heart Institute, Mexico:

Primary Outcome Measures:

improvement of endothelial function [ Time Frame: 12 weeks ]
Basal and final (12 weeks) endothelial function parameters measured by PET scan

Secondary Outcome Measures:

change in HDL particle physicochemical characteristics [ Time Frame: 12 weeks ]
HDL particle size, distribution and composition evaluated at baseline and at 12 weeks


Enrollment:	30
Study Start Date:	March 2007
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: sugar pill tablet similar to comparator	Drug: placebo tablet taken once a day
Active Comparator: pioglitazone 30 mg tablets QD (taken once daily)	Drug: pioglitazone 30 mg tablet QD (taken once daily) Other Names: actos zactos

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).

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322308

Sponsors and Collaborators

National Heart Institute, Mexico

National Council of Science and Technology, Mexico

Universidad Nacional Autonoma de Mexico

Investigators


Study Chair:	Carlos Posadas, MD	Head of the Endocrinology Department

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Juárez-Rojas JG, Medina-Urrutia AX, Jorge-Galarza E, Caracas-Portilla NA, Posadas-Sánchez R, Cardoso-Saldaña GC, Goycochea-Robles MV, Silveira LH, Lino-Pérez L, Mas-Oliva J, Pérez-Méndez O, Posadas-Romero C. Pioglitazone improves the cardiovascular profile in patients with uncomplicated systemic lupus erythematosus: a double-blind randomized clinical trial. Lupus. 2012 Jan;21(1):27-35. doi: 10.1177/0961203311422096. Epub 2011 Oct 12.


Responsible Party:	Nacu Caracas Portilla, Juan Gabriel Juarez Rojas PhD, National Heart Institute, Mexico
ClinicalTrials.gov Identifier:	NCT01322308 History of Changes
Other Study ID Numbers:	05-487
Study First Received:	March 23, 2011
Last Updated:	September 30, 2014

Keywords provided by Nacu Caracas Portilla, National Heart Institute, Mexico:


lupus HDL particles endothelial function pioglitazone

Additional relevant MeSH terms:


Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases	Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 19, 2017

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