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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alejandra Guillermina Miranda Diaz, University of Guadalajara

ClinicalTrials.gov Identifier:

NCT01622777

First received: June 15, 2012

Last updated: June 18, 2012

Last verified: June 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Diabetic Polyneuropathy	Drug: Rosuvastatin Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Alejandra Guillermina Miranda Diaz, University of Guadalajara:

Primary Outcome Measures:

Stage of diabetic polyneuropathy [ Time Frame: 12 weeks ]
Severity of diabetic polyneuropathy [ Time Frame: 12 weeks ]
Severity according nerve conduction studies
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 ]


Enrollment:	34
Study Start Date:	February 2010
Study Completion Date:	June 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	35 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622777

Locations


Mexico
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

More Information


Responsible Party:	Alejandra Guillermina Miranda Diaz, Investigator of Cardiovascular Research Unit, University of Guadalajara
ClinicalTrials.gov Identifier:	NCT01622777 History of Changes
Other Study ID Numbers:	ROSU001
Study First Received:	June 15, 2012
Last Updated:	June 18, 2012

Keywords provided by Alejandra Guillermina Miranda Diaz, University of Guadalajara:


Rosuvastatin Diabetic polyneuropathy Nerve conduction Oxidative stress Nerve growth factor

Additional relevant MeSH terms:


Polyneuropathies Diabetic Neuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases	Rosuvastatin Calcium Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 21, 2017

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