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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05184049
• Other study ID #: 20210406
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2022
• Est. completion date: October 2023

Study information

• Verified date: October 2021
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Peripheral Nervous System Diseases

Intervention

Drug:
• 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.
• Mecobalamin
Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean change of electromyography	mean change from baseline in nerve conduction velocity(m/s) after 6-months treatment	baseline , 6months
Secondary	Mean change of quantitative somatosensory testing	Mean change of temperature perception threshold(?) after 6-months treatment	baseline , 6months
Secondary	Mean change of corneal confocal focus	Mean change of nerve fibre density(no./mm2) after 6-months treatment	baseline , 6months
Secondary	Mean change in HbA1c	Mean change of HbA1c(%) after 6-months treatment	baseline , 6months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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