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

Alejandra Guillermina Miranda Diaz34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetic Polyneuropathy

Interventions

RosuvastatinDRUG

20 mg daily of oral rosuvastatin for 12 weeks

PlaceboDRUG

100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiovascular Research Unit. University of Guadalajara.

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Stage of diabetic polyneuropathy

Time frame: 12 weeks

Severity of diabetic polyneuropathy

Severity according nerve conduction studies

Time frame: 12 weeks

Nerve conduction studies

Time frame: 12 weeks

Neuropathy symptoms and impairment scores

Time frame: 12 weeks

Lipid peroxidation

Time frame: 12 weeks

Nerve growth factor

Time frame: 12 weeks

Data from ClinicalTrials.gov

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