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NCT Number: NCT01622777

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

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

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Key information

Conditions

Diabetic Polyneuropathy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardiovascular Research Unit. University of Guadalajara.

Guadalajara, Jalisco, 44340, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

20 mg daily of oral rosuvastatin for 12 weeks

Placebo

Drug

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

Primary outcomes

  1. Stage of diabetic polyneuropathy

    Time frame: 12 weeks

  2. Severity of diabetic polyneuropathy

    Time frame: 12 weeks

    Severity according nerve conduction studies

  3. Nerve conduction studies

    Time frame: 12 weeks

  4. Neuropathy symptoms and impairment scores

    Time frame: 12 weeks

  5. Lipid peroxidation

    Time frame: 12 weeks

  6. Nerve growth factor

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Alejandra Guillermina Miranda Diaz

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 19, 2012
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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