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

Central South University

Status and phase: Unknown; Phase 4

Conditions: Diabetes

Treatments: Drug: Epalrestat,Mecobalamin; Drug: Mecobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT05184049

20210406

Details and patient eligibility

About

This study evaluated the efficacy of epalrestat in diabetic peripheral neuropathy and its effects on the central nervous system in diabetic peripheral neuropathy subjects.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 to 65 years (to the date of screening)；
2. A clear history of type 2 diabetes (using the 1999 WHO diabetes diagnostic criteria) with a course of disease > 6 months;
3. HbA1c < 7%;
4. 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;
5. 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

1. Neuropathy caused by other causes, such as cervical and lumbar lesions, cerebral infarction, etc.;
2. With acute metabolic complications of diabetes, such as ketoacidosis, lactic acidosis, diabetes hyperotonic state, etc;
3. Severe cardiovascular and cerebrovascular diseases , pulmonary heart disease or pulmonary insufficiency, renal failure, severe dyslipidemia, poorly controlled hypertension, severe hepatitis.
4. Those with a history of malignant tumor or wasting diseases such as tuberculosis;
5. Contraindications to MRI scanning: such as internal (especially oral) metal implants, claustrophobia, etc;
6. Poor compliance or serious side effects;
7. pregnant female.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Epalrestat

Experimental group

Description:

oral epalrestat (50mg/ time, 3 times/day) + conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year

Treatment:

Drug: Epalrestat,Mecobalamin

The control group

Experimental group

Description:

conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year

Treatment:

Drug: Mecobalamin