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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pioglitazone
placebo
Sponsored by
National Heart Institute, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring lupus, HDL particles, endothelial function, pioglitazone

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    sugar pill

    pioglitazone

    Arm Description

    tablet similar to comparator

    30 mg tablets QD (taken once daily)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    change in HDL particle physicochemical characteristics
    HDL particle size, distribution and composition evaluated at baseline and at 12 weeks

    Full Information

    First Posted
    March 23, 2011
    Last Updated
    September 30, 2014
    Sponsor
    National Heart Institute, Mexico
    Collaborators
    National Council of Science and Technology, Mexico, Universidad Nacional Autonoma de Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01322308
    Brief Title
    Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Heart Institute, Mexico
    Collaborators
    National Council of Science and Technology, Mexico, Universidad Nacional Autonoma de Mexico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus
    Keywords
    lupus, HDL particles, endothelial function, pioglitazone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sugar pill
    Arm Type
    Placebo Comparator
    Arm Description
    tablet similar to comparator
    Arm Title
    pioglitazone
    Arm Type
    Active Comparator
    Arm Description
    30 mg tablets QD (taken once daily)
    Intervention Type
    Drug
    Intervention Name(s)
    pioglitazone
    Other Intervention Name(s)
    actos, zactos
    Intervention Description
    30 mg tablet QD (taken once daily)
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    tablet taken once a day
    Primary Outcome Measure Information:
    Title
    improvement of endothelial function
    Description
    Basal and final (12 weeks) endothelial function parameters measured by PET scan
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    change in HDL particle physicochemical characteristics
    Description
    HDL particle size, distribution and composition evaluated at baseline and at 12 weeks
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos Posadas, MD
    Organizational Affiliation
    Head of the Endocrinology Department
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21993383
    Citation
    Juarez-Rojas JG, Medina-Urrutia AX, Jorge-Galarza E, Caracas-Portilla NA, Posadas-Sanchez R, Cardoso-Saldana GC, Goycochea-Robles MV, Silveira LH, Lino-Perez L, Mas-Oliva J, Perez-Mendez 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.
    Results Reference
    derived

    Learn more about this trial

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

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