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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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 23, 2014