A Randomized, Single-center, Parallel-group, Prospective Trial of Neuroprotective Effect of Epalrestat for Treatment of Diabetic Polyneuropathy.
Not Applicable
- Conditions
- Diabetic Polyneuropathy
- Registration Number
- JPRN-UMIN000019634
- Lead Sponsor
- Aichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1. Pregnancy, lactation 2. Type 1 diabetes, othertypes of diabetes 3. Past history of diabetic ketoacidosis 4. Severe infection, Pre-/post-operation, Severe injuries 5. Treatment with steroids 6. Current/Past malignancy 7. Inappropriate patients for entry on this study in the judgement of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change from screening in corneal confocal microscopic findings at month 36 2. Change from screening in nerve conduction studies at month 36
- Secondary Outcome Measures
Name Time Method 1. Score of Michigan Neuropathy Screening Instrument(MNSI) 2. Clinical findings: i) Absent or hypoactive Achilles tendon reflexes, ii) Impaired vibration sensation 3. HbA1c, blood glucose 4. Coefficients of variance of RR intervals 5. Diabetic nephropathy, Diabetic retinopathy 6. Laboratory data, blood pressure 7. safety