Statins for Oxidative Stress and Mitochondrial Function in Diabetic Polyneuropathy

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Aims: To evaluate the effect of ezetimibe/simvastatin and rosuvastatin on oxidative stress and mitochondrial function in patients with DPN.

Methods: We performed a randomized, double-blinded, placebo-controlled phase II clinical trial in adult patients with type 2 Diabetes Mellitus (T2DM) who had Diabetic Polyneuropathy (DPN) evaluated by composite scores and nerve conduction studies (NCS), HBA1C <12% (108 mmol/mol), previous exclusion of other neuropathies. Ninety-eight persons with T2DM were allocated 1:1:1 to either placebo, ezetimibe/simvastatin 10/20 mg or rosuvastatin 20 mg for 16 weeks, and healthy controls (not randomized) were included for comparisons. Primary outcomes were lipid peroxidation (LPO), nitric oxide (NO), and total antioxidant capacity (TAC); secondary were clinical, NCS and metabolic parameters. Results were expressed as mean ± standard deviation (SD) or standard error of the mean (SEM), frequencies and percentages. Non-parametric analysis was used.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Magnesium Oxide; Rosuvastatin Calcium; Simvastatin

Criteria

Inclusion Criteria:

• 18 years old and older

• Type 2 Diabetes Mellitus according to American Diabetes Association

• Diabetic Polyneuropathy by Dyck et. al. criteria

• HbA1c <12%

• Informed consent signed

Exclusion Criteria:

• Renal or hepatic failure

• Pregnant or breastfeeding

• Other neuropathies (alcohol-induced, radiculopathy, autoimmune, cancer-related)