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

Diabetic Polyneuropathy Clinical Trial

Official title:

Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622777
• Other study ID #: ROSU001
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2012
• Last updated: June 18, 2012
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Drug:
• Rosuvastatin
20 mg daily of oral rosuvastatin for 12 weeks
• Placebo
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks

Locations

Country	Name	City	State
Mexico	Cardiovascular Research Unit. University of Guadalajara.	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Alejandra Guillermina Miranda Diaz

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage of diabetic polyneuropathy		12 weeks	No
Primary	Severity of diabetic polyneuropathy	Severity according nerve conduction studies	12 weeks	No
Primary	Nerve conduction studies		12 weeks	No
Primary	Neuropathy symptoms and impairment scores		12 weeks	No
Primary	Lipid peroxidation		12 weeks	No
Primary	Nerve growth factor		12 weeks	No