Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patient

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Epalrestat,Mecobalamin
* Drug: Mecobalamin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 65 years (to the date of screening)； A clear history of type 2 diabetes (using the 1999 WHO diabetes diagnostic criteria) with a course of disease > 6 months; HbA1c < 7%; Two or more of the following five tests are abnormal: abnormal temperature perception; Nylon wire for hypoesthesia or disappearance of the foot; Abnormal vibration sense; Ankle reflex disappeared; Two or more nerve conduction velocities were reduced; Have not used mecobalamin, epalrestat, lipoic acid or high-dose glucocorticoid in the recent (3 months) period, or have not been involved in other treatment of the same disease within 3 months prior to the study; Exclusion Criteria: Neuropathy caused by other causes, such as cervical and lumbar lesions, cerebral infarction, etc.; With acute metabolic complications of diabetes, such as ketoacidosis, lactic acidosis, diabetes hyperotonic state, etc; Severe cardiovascular and cerebrovascular diseases , pulmonary heart disease or pulmonary insufficiency, renal failure, severe dyslipidemia, poorly controlled hypertension, severe hepatitis. Those with a history of malignant tumor or wasting diseases such as tuberculosis; Contraindications to MRI scanning: such as internal (especially oral) metal implants, claustrophobia, etc; Poor compliance or serious side effects; pregnant female.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epalrestat<br>oral epalrestat (50mg/ time, 3 times/day) + conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year | Drug: Epalrestat,Mecobalamin<br>* 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.<br>|
| Experimental: The control group<br>conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year | Drug: Mecobalamin<br>* Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |