The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study
This study has been completed.
Sponsor:
Alejandra Guillermina Miranda Diaz
Information provided by (Responsible Party):
Alejandra Guillermina Miranda Diaz, University of Guadalajara
ClinicalTrials.gov Identifier:
NCT01622777
First received: June 15, 2012
Last updated: June 18, 2012
Last verified: June 2012
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Purpose
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Polyneuropathy |
Drug: Rosuvastatin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy |
Resource links provided by NLM:
Further study details as provided by University of Guadalajara:
Primary Outcome Measures:
- Stage of diabetic polyneuropathy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Severity of diabetic polyneuropathy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Severity according nerve conduction studies
- Nerve conduction studies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Neuropathy symptoms and impairment scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Lipid peroxidation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Nerve growth factor [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rosuvastatin
20 mg daily of oral rosuvastatin
|
Drug: Rosuvastatin
20 mg daily of oral rosuvastatin for 12 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks
|
Eligibility| Ages Eligible for Study: | 35 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with type 2 diabetes mellitus
- Glycated hemoglobin <12.0%
- Signing of informed consent
- Presence of an abnormality of nerve conduction study
- Symptoms and signs of diabetic polyneuropathy
Exclusion Criteria:
- Pregnancy and lactation
- Foot ulcers
- Treatment with statins
- Antioxidant drug and/or supplements one month previous to enrolment
- Inability to mobilize
- Renal and/or hepatic failure
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01622777
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622777
Locations
| Mexico | |
| Cardiovascular Research Unit. University of Guadalajara. | |
| Guadalajara, Jalisco, Mexico, 44340 | |
Sponsors and Collaborators
Alejandra Guillermina Miranda Diaz
Investigators
| Study Director: | Ernesto G. Cardona-Muñoz, MD, PhD | University of Guadalajara | |
| Study Chair: | Luis Miguel Roman-Pintos, MD,PhD | University of Guadalajara | |
| Study Chair: | Rogelio Troyo-Sanroman, PhD | University of Guadalajara | |
| Study Chair: | María del Pilar Alatorre-Carranza, PhD | Hospital Civil de Guadalajara | |
| Study Director: | Alejandra G. Miranda-Diaz, MD, PhD | University of Guadalajara | |
| Principal Investigator: | Jaime Hernandez-Ojeda, MD, PhD | University of Guadalajara |
More Information
No publications provided
| Responsible Party: | Alejandra Guillermina Miranda Diaz, Investigator of Cardiovascular Research Unit, University of Guadalajara |
| ClinicalTrials.gov Identifier: | NCT01622777 History of Changes |
| Other Study ID Numbers: | ROSU001 |
| Study First Received: | June 15, 2012 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Mexico: Ethics Committee |
Keywords provided by University of Guadalajara:
|
Rosuvastatin Diabetic polyneuropathy Nerve conduction Oxidative stress Nerve growth factor |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Polyneuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Rosuvastatin |
Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015