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

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: Diabetic Polyneuropathy
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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		12 weeks
Severity of diabetic polyneuropathy	Severity according nerve conduction studies	12 weeks
Nerve conduction studies		12 weeks
Neuropathy symptoms and impairment scores		12 weeks
Lipid peroxidation		12 weeks
Nerve growth factor		12 weeks

Collaborators and Investigators

• 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

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: Oxidative stress; Rosuvastatin; Nerve conduction; Nerve growth factor; Diabetic polyneuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: ROSU001