Diabetic peripheral neuropathy
Conditions
Interventions
Epalrestat(50mg) was orally administered three times daily before each meal (150 mg/day) with conventional therapies
Conventional therapy (diet treatment, hypoglycemic agents, insulin, and hypotensive
Sponsors
The Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT) Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged =>20 years were diagnosed in each facilities as mild diabetic peripheral neuropathy based on subjective symptoms, no foot ulcer and neurological dysfunctions (at least two parameters; MNCV [indispensable] and VPT or Achilles tendon reflex, etc.). Patients were enrolled for study if they had a median motor nerve conduction velocity (MNCV) =>40 m/s (seemingly reversible) and stable glycemic control (HbA1c <=9%, with +/- 0.5% variation in the previous 3 months).
Exclusion criteria
Exclusion criteria: Subjects were excluded if their primary cause of neurologic disorder was not diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease, etc.), if they had arteriosclerosis obliterans (ankle brachial pressure index of <=0.8), or severe hepatic or renal disorder, if they were participating in other interventional studies, or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in median MNCV at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Other somatic nerve function parameters (minimum F-wave latency [MFWL] of the median motor nerve and vibration perception threshold [VPT]), cardiovascular autonomic nerve function and subjective symptoms | — |
Countries
Japan
Contacts
Public ContactNigishi Hotta
Japan Labour Health and Welfare Organization CHUBU ROSAI HOSPITAL Director General
Outcome results
None listed