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A Randomized, Single-center, Parallel-group, Prospective Trial of Neuroprotective Effect of Liraglutide for Treatment of Diabetic Polyneuropathy.

Not Applicable
Conditions
Diabetic Polyneuropathy
Registration Number
JPRN-UMIN000021915
Lead Sponsor
Aichi Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

1. Pregnancy, lactation 2. Allergic to Liraglutide 3. Past usage of GLP-1 receptor agonists or DPP4 inhibitors 4. Type 1 diabetes, othertypes of diabetes 5. Past history of diabetic ketoacidosis 6. Severe infection, Pre-/post-operation, Severe injuries 7. Treatment with steroids 8. Current/Past malignancy 9. 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
NameTimeMethod
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
NameTimeMethod
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. Current perception threshold, Electronic pupillometer, Electroretinography 8. Mini Mental State Examination(MMSE) 9. Safety
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