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

Alejandra Guillermina Miranda Diaz

Status and phase: Completed; Phase 2

Conditions: Diabetic Polyneuropathy

Treatments: Drug: Rosuvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01622777

ROSU001

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Rosuvastatin

Experimental group

Description:

20 mg daily of oral rosuvastatin

Treatment:

Drug: Rosuvastatin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo