Status:
UNKNOWN
Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patients
Lead Sponsor:
Xiangya Hospital of Central South University
Conditions:
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05184049
Start Date
January 1 2022
End Date
October 1 2023
Last Update
January 11 2022
Active Locations (1)
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1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008