Diabetic Polyneuropathy
Conditions
Keywords
Rosuvastatin, Diabetic polyneuropathy, Nerve conduction, Oxidative stress, Nerve growth factor
Brief summary
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.
Interventions
DRUGRosuvastatin
20 mg daily of oral rosuvastatin for 12 weeks
DRUGPlacebo
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks
Sponsors
Alejandra Guillermina Miranda Diaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage of diabetic polyneuropathy | 12 weeks | — |
| Severity of diabetic polyneuropathy | 12 weeks | Severity according nerve conduction studies |
| Nerve conduction studies | 12 weeks | — |
| Neuropathy symptoms and impairment scores | 12 weeks | — |
| Lipid peroxidation | 12 weeks | — |
| Nerve growth factor | 12 weeks | — |
Countries
Mexico
Outcome results
None listed