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

Primary Purpose

Diabetic Polyneuropathy

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
Alejandra Guillermina Miranda Diaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring Rosuvastatin, Diabetic polyneuropathy, Nerve conduction, Oxidative stress, Nerve growth factor

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Research Unit. University of Guadalajara.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rosuvastatin

Placebo

Arm Description

20 mg daily of oral rosuvastatin

Outcomes

Primary Outcome Measures

Stage of diabetic polyneuropathy
Severity of diabetic polyneuropathy
Severity according nerve conduction studies
Nerve conduction studies
Neuropathy symptoms and impairment scores
Lipid peroxidation
Nerve growth factor

Secondary Outcome Measures

Full Information

First Posted
June 15, 2012
Last Updated
June 18, 2012
Sponsor
Alejandra Guillermina Miranda Diaz
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1. Study Identification

Unique Protocol Identification Number
NCT01622777
Brief Title
The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study
Official Title
Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alejandra Guillermina Miranda Diaz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy
Keywords
Rosuvastatin, Diabetic polyneuropathy, Nerve conduction, Oxidative stress, Nerve growth factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
20 mg daily of oral rosuvastatin
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
20 mg daily of oral rosuvastatin for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks
Primary Outcome Measure Information:
Title
Stage of diabetic polyneuropathy
Time Frame
12 weeks
Title
Severity of diabetic polyneuropathy
Description
Severity according nerve conduction studies
Time Frame
12 weeks
Title
Nerve conduction studies
Time Frame
12 weeks
Title
Neuropathy symptoms and impairment scores
Time Frame
12 weeks
Title
Lipid peroxidation
Time Frame
12 weeks
Title
Nerve growth factor
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernesto G. Cardona-Muñoz, MD, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luis Miguel Roman-Pintos, MD,PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rogelio Troyo-Sanroman, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
María del Pilar Alatorre-Carranza, PhD
Organizational Affiliation
Hospital Civil de Guadalajara
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alejandra G. Miranda-Diaz, MD, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jaime Hernandez-Ojeda, MD, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Research Unit. University of Guadalajara.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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