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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01622777
First Posted: June 19, 2012
Last Update Posted: June 20, 2012
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.
Information provided by (Responsible Party):
Alejandra Guillermina Miranda Diaz, University of Guadalajara
  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
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

Resource links provided by NLM:


Further study details as provided by Alejandra Guillermina Miranda Diaz, University of Guadalajara:

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

  • Nerve conduction studies [ Time Frame: 12 weeks ]
  • Neuropathy symptoms and impairment scores [ Time Frame: 12 weeks ]
  • Lipid peroxidation [ Time Frame: 12 weeks ]
  • Nerve growth factor [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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
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

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
First Submitted: June 15, 2012
First Posted: June 19, 2012
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:
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