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Statins for Oxidative Stress and Mitochondrial Function in Diabetic Polyneuropathy

NCT02129231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2014-05-06

No results posted yet for this study

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.

Conditions

  • Oxidative Stress
  • Diabetic Polyneuropathy

Interventions

DRUG

calcined magnesia

We ensured the patient took the drug at night before meals

DRUG

Ezetimibe/simvastatin

We ensured the patient took the drug at night before meals

DRUG

Rosuvastatin

We ensured the patient took the drug at night before meals

Sponsors & Collaborators

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • Luis M Roman-Pintos, PhD, MD · University of Guadalajara

  • Alejandra G Miranda-Diaz, PhD,MD,FACS · University of Guadalajara

  • Adolfo D Rodriguez-Carrizalez, PhD, MD · University of Guadalajara

  • Geannyne Villegas-Rivera, PhD, MD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02129231 on ClinicalTrials.gov