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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rosuvastatin

20 mg daily of oral rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

20 mg daily of oral rosuvastatin for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Rosuvastatin

20 mg daily of oral rosuvastatin for 12 weeks

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No