Systemic Lupus ErythematosusPhase 4NCT01322308
Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus
A Phase 4 study testing pioglitazone in people with Systemic Lupus Erythematosus, run by National Heart Institute, Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Eligible participants were premenopausal women with SLE
- Older than 18 years
- Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary care hospitals
Who cannot join
- menopause
- diabetes
- thyroid dysfunction
- neurological
- hepatic
- renal or liver disease
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- 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
About this study
Official title: Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Read the 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).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- pioglitazone, placebo
- Keywords
- lupus, HDL particles, endothelial function, pioglitazone
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Also called actos, zactos
30 mg tablet QD (taken once daily)
placeboDrug
tablet taken once a day
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | tablet similar to comparator Receives: Drug: placebo |
| pioglitazone | Active comparator | 30 mg tablets QD (taken once daily) Receives: Drug: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of endothelial function
Basal and final (12 weeks) endothelial function parameters measured by PET scan
Measured: 12 weeks
Secondary outcomes (1)
change in HDL particle physicochemical characteristics
HDL particle size, distribution and composition evaluated at baseline and at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMar 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Institute, Mexico
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico, Universidad Nacional Autonoma de Mexico
- Responsible party
- Principal investigator, Nacu Caracas Portilla, National Heart Institute, Mexico
- Investigators
- Carlos Posadas, MD, Study chair, Head of the Endocrinology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322308
- Sponsor's protocol ID
- 05-487
- Status last verified
- Sep 2014
- First submitted
- 23 Mar 2011
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21993383
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01322308
- Acronym / sponsor ID
- 05-487
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus, HDL particles, endothelial function, pioglitazone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Heart Institute, MexicoOther government
- Collaborators
- National Council of Science and Technology, Mexico, Universidad Nacional Autonoma de Mexico
- Study start
- Mar 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Drug: placebotablet similar to comparator |
| pioglitazone | Active comparator | Drug: pioglitazone30 mg tablets QD (taken once daily) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eligible participants were premenopausal women with SLE
- Older than 18 years
- Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary care hospitals
Key exclusion criteria (15 listed)
- menopause
- diabetes
- thyroid dysfunction
- neurological
- hepatic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazoneAlso: actos, zactos30 mg tablet QD (taken once daily) | Drug | pioglitazone |
| placebotablet taken once a day | Drug | sugar pill |
Primary outcome
improvement of endothelial function
Time frame: 12 weeks
Basal and final (12 weeks) endothelial function parameters measured by PET scan
1 secondary outcome
change in HDL particle physicochemical characteristics
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Derived from this study: PubMed 21993383Juarez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Posadas, MD study chair
Head of the Endocrinology Department
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pioglitazone in people with Systemic Lupus Erythematosus, run by National Heart Institute, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of endothelial function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.