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

Phase 2

Completed

• Conditions: Diabetic Polyneuropathy
• Interventions: Drug: Placebo; Drug: Rosuvastatin

• Registration Number: NCT01622777
• Lead Sponsor: Alejandra Guillermina Miranda Diaz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-01
• Study Completion: 2011-06
• Status Verified: 2012-06
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-15
• Last Update Submitted: 2012-06-18
• Study First Posted: 2012-06-19
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Rosuvastatin	Rosuvastatin	20 mg daily of oral rosuvastatin

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular Research Unit. University of Guadalajara.; 🇲🇽 Guadalajara, Jalisco, Mexico