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This study evaluated the efficacy of epalrestat in diabetic peripheral neuropathy and its effects on the central nervous system in diabetic peripheral neuropathy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epalrestat | Experimental | oral epalrestat (50mg/ time, 3 times/day) + conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year |
|
| The control group | Experimental | conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epalrestat,Mecobalamin | Drug | Epalrestat will be taken orally at a dose of 50mg 3 times a day before meals. In addition, conventional hypoglycemic and oral mecobalamin treatment 0.5mg/ time, 3 times/day, before meals. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of resting-state functional Magnetic Resonance Imaging | The change in grey matter volume,white matter area, local gyrification index after 6-months treatment | baseline , 6months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of electromyography | mean change from baseline in nerve conduction velocity(m/s) after 6-months treatment | baseline , 6months |
| Mean change of quantitative somatosensory testing | Mean change of temperature perception threshold(℃) after 6-months treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C038131 | epalrestat |
| C019476 | mecobalamin |
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| Mecobalamin | Drug | Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia. |
|
| baseline , 6months |
| Mean change of corneal confocal focus | Mean change of nerve fibre density(no./mm2) after 6-months treatment | baseline , 6months |
| Mean change in HbA1c | Mean change of HbA1c(%) after 6-months treatment | baseline , 6months |
| Change of Self-Rating Anxiety Scale | Mean change of Self-Rating Anxiety Scale score after 6-months treatment score.The minimum and maximum values is 25 and 100, which higher scores mean more anxiety. | baseline , 6months |
| Change of Self-Rating Depression Scale | Mean change of Self-Rating Depression Scale score after 6-months treatment.The minimum and maximum values is 25 and 100, which higher scores mean more depression. | baseline , 6months |
| Mean change of Toronto clinical scoring system | Mean change of Toronto clinical scoring system score after 6-months treatment.The minimum and maximum values is 0 and 19, which higher scores mean more severe neuropathy. | baseline , 6months |
| Mean change of Neuropathic pain scale | Mean change of Neuropathic pain scale score after 6-months treatment.The minimum and maximum values is 0 and 10, which higher scores mean more severe neuropathy. | baseline , 6months |
| Mean change of Michigan neuropathy screening form | Mean change of Michigan neuropathy screening form score after 6-months treatment.The minimum and maximum values is 0 and 23, which higher scores mean more severe neuropathy. | baseline , 6months |
| Mean change of mini-mental state examination | Mean change of mini-mental state examination score after 6-months treatment.The minimum and maximum values is 0 and 30, which lower scores mean more severe cognitive dysfunction. | baseline , 6months |
| Mean change of Montreal Cognitive Assessment | Mean change of Montreal Cognitive Assessment score after 6-months treatment.The minimum and maximum values is 0 and 30, which lower scores mean more severe cognitive dysfunction. | baseline , 6months |