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

NCT ID: NCT05184049

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-10-31

Brief Summary

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

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epalrestat

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

Group Type: EXPERIMENTAL

Epalrestat,Mecobalamin

Intervention Type: 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.

The control group

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

Group Type: EXPERIMENTAL

Mecobalamin

Intervention Type: DRUG

Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.

Interventions

Epalrestat,Mecobalamin

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.

Intervention Type: DRUG

Mecobalamin

Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jing Wu

Role: primary

wujing0731@163.com

+86-13574120508

Other Identifiers

20210406

Identifier Type: -

Identifier Source: org_study_id