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To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | 20 mg daily of oral rosuvastatin |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 20 mg daily of oral rosuvastatin for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stage of diabetic polyneuropathy | 12 weeks | |
| Severity of diabetic polyneuropathy | Severity according nerve conduction studies | 12 weeks |
| Nerve conduction studies | 12 weeks | |
| Neuropathy symptoms and impairment scores | 12 weeks | |
| Lipid peroxidation | 12 weeks | |
| Nerve growth factor | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto G. Cardona-Muñoz, MD, PhD | University of Guadalajara | Study Director |
| Luis Miguel Roman-Pintos, MD,PhD | University of Guadalajara | Study Chair |
| Rogelio Troyo-Sanroman, PhD | University of Guadalajara | Study Chair |
| MarÃa del Pilar Alatorre-Carranza, PhD | Hospital Civil de Guadalajara | Study Chair |
| Alejandra G. Miranda-Diaz, MD, PhD | University of Guadalajara | Study Director |
| Jaime Hernandez-Ojeda, MD, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research Unit. University of Guadalajara. | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Placebo |
| Drug |
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks |
|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |