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

June 18, 2012 updated by: Alejandra Guillermina Miranda Diaz

Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy

To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Cardiovascular Research Unit. University of Guadalajara.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks
Experimental: Rosuvastatin
20 mg daily of oral rosuvastatin
Drug: Rosuvastatin
20 mg daily of oral rosuvastatin for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage of diabetic polyneuropathy
Time Frame: 12 weeks
12 weeks
Severity of diabetic polyneuropathy
Time Frame: 12 weeks
Severity according nerve conduction studies
12 weeks
Nerve conduction studies
Time Frame: 12 weeks
12 weeks
Neuropathy symptoms and impairment scores
Time Frame: 12 weeks
12 weeks
Lipid peroxidation
Time Frame: 12 weeks
12 weeks
Nerve growth factor
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROSU001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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