The study to evaluate effects of a short term improvement of hyperglycemia in diabetic polyneuropathy
Not Applicable
Recruiting
- Conditions
- Diabetic Polyneuropathy
- Registration Number
- JPRN-UMIN000021914
- Lead Sponsor
- Aichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1. Pregnancy, lactation 2. Severe infection, Severe injuries 3. Treatment with steroids 4. Current/Past malignancy 5. Allergic to anesthetic drugs 6. Inappropriate patients for entry on this study in the judgement of the investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change from screening in corneal confocal microscopic findings at week 2 and month 36 2. Change from screening in nerve conduction studies at week 2 and month 36
- Secondary Outcome Measures
Name Time Method Changes from screeining in tests as below at week 2 and month 36 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 8. Current potential threshold 9. Iriscorder 10. Elctroretinography