NCT01322308

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

4.8 years

First QC Date

March 23, 2011

Last Update Submit

September 30, 2014

Conditions

Systemic Lupus Erythematosus

Keywords

lupusHDL particlesendothelial functionpioglitazone

Outcome Measures

Primary Outcomes (1)

  • improvement of endothelial function

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

    12 weeks

Secondary Outcomes (1)

  • change in HDL particle physicochemical characteristics

    12 weeks

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

tablet similar to comparator

Drug: placebo

pioglitazone

ACTIVE COMPARATOR

30 mg tablets QD (taken once daily)

Drug: pioglitazone

Interventions

pioglitazoneDRUG

30 mg tablet QD (taken once daily)

Also known as: actos, zactos
pioglitazone
placeboDRUG

tablet taken once a day

sugar pill

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible participants were premenopausal women with SLE
  • Older than 18 years
  • Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary care hospitals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21993383DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Carlos Posadas, MD

    Head of the Endocrinology Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Juan Gabriel Juarez Rojas PhD

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

March 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 1, 2014

Record last verified: 2014-09