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

• Sponsor: Alejandra Guillermina Miranda Diaz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01622777
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 15.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Polyneuropathy	Drug: Rosuvastatin; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rosuvastatin 20 mg daily of oral rosuvastatin	Drug: Rosuvastatin; 20 mg daily of oral rosuvastatin for 12 weeks
Placebo Comparator: Placebo	Drug: Placebo; 100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Stage of diabetic polyneuropathy [12 weeks]

2. Severity of diabetic polyneuropathy [12 weeks]

   Severity according nerve conduction studies

3. Nerve conduction studies [12 weeks]

4. Neuropathy symptoms and impairment scores [12 weeks]

5. Lipid peroxidation [12 weeks]

6. Nerve growth factor [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Research Unit. University of Guadalajara.	Guadalajara	Jalisco	Mexico	44340

Sponsors and Collaborators

• Alejandra Guillermina Miranda Diaz

Investigators

• Study Director: Ernesto G. Cardona-Muñoz, MD, PhD, University of Guadalajara
• Study Chair: Luis Miguel Roman-Pintos, MD,PhD, University of Guadalajara
• Study Chair: Rogelio Troyo-Sanroman, PhD, University of Guadalajara
• Study Chair: María del Pilar Alatorre-Carranza, PhD, Hospital Civil de Guadalajara
• Study Director: Alejandra G. Miranda-Diaz, MD, PhD, University of Guadalajara
• Principal Investigator: Jaime Hernandez-Ojeda, MD, PhD, University of Guadalajara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alejandra Guillermina Miranda Diaz, Investigator of Cardiovascular Research Unit, University of Guadalajara
• ClinicalTrials.gov Identifier: NCT01622777
• Other Study ID Numbers: ROSU001
• First Posted: Jun 19, 2012
• Last Update Posted: Jun 20, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Alejandra Guillermina Miranda Diaz, Investigator of Cardiovascular Research Unit, University of Guadalajara: Rosuvastatin; Diabetic polyneuropathy; Nerve conduction; Oxidative stress; Nerve growth factor
• Additional relevant MeSH terms: Polyneuropathies; Diabetic Neuropathies; Rosuvastatin Calcium

Study Results

No Results Posted as of Jun 20, 2012