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The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01622777
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Alejandra Guillermina Miranda Diaz, University of Guadalajara

Study Description
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Brief Summary:
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.

Condition or disease Intervention/treatment Phase
Diabetic Polyneuropathy Drug: Rosuvastatin Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Stage of diabetic polyneuropathy [ Time Frame: 12 weeks ]
  2. Severity of diabetic polyneuropathy [ Time Frame: 12 weeks ]
    Severity according nerve conduction studies

  3. Nerve conduction studies [ Time Frame: 12 weeks ]
  4. Neuropathy symptoms and impairment scores [ Time Frame: 12 weeks ]
  5. Lipid peroxidation [ Time Frame: 12 weeks ]
  6. Nerve growth factor [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622777


Locations
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Mexico
Cardiovascular Research Unit. University of Guadalajara.
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Alejandra Guillermina Miranda Diaz
Investigators
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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
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Responsible Party: Alejandra Guillermina Miranda Diaz, Investigator of Cardiovascular Research Unit, University of Guadalajara
ClinicalTrials.gov Identifier: NCT01622777    
Other Study ID Numbers: ROSU001
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012
Keywords provided by Alejandra Guillermina Miranda Diaz, University of Guadalajara:
Rosuvastatin
Diabetic polyneuropathy
Nerve conduction
Oxidative stress
Nerve growth factor
Additional relevant MeSH terms:
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Polyneuropathies
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors