ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01322308
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : October 1, 2014
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: pioglitazone Drug: placebo Phase 4

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).


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : March 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 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