Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Lupus
U.S. FDA Resources

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

Primary Outcome Measures:
  • improvement of endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Other Name: placebo
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
Genders 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

No publications provided by National Heart Institute, Mexico

Additional 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
Study First Received: March 23, 2011
Last Updated: September 30, 2014
Health Authority: Mexico: Secretaria de Salud

Keywords provided by National Heart Institute, Mexico:
lupus
HDL particles
endothelial function
pioglitazone

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
 Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015