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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
| Universidad Nacional Autonoma de Mexico | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugar pill | Placebo Comparator | tablet similar to comparator |
|
| pioglitazone | Active Comparator | 30 mg tablets QD (taken once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | 30 mg tablet QD (taken once daily) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement of endothelial function | Basal and final (12 weeks) endothelial function parameters measured by PET scan | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in HDL particle physicochemical characteristics | HDL particle size, distribution and composition evaluated at baseline and at 12 weeks | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Posadas, MD | Head of the Endocrinology Department | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21993383 | Derived | 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. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| placebo | Drug | tablet taken once a day |
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |