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

NCT05184049 | Unknown Phase 4

• 1 other identifier: 20210406
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Mean change of electromyography

  baseline , 6months

• Mean change of quantitative somatosensory testing

  baseline , 6months

• Mean change of corneal confocal focus

  baseline , 6months

• Mean change in HbA1c

  baseline , 6months

• Change of Self-Rating Anxiety Scale

  baseline , 6months

Study Arms (2)

Epalrestat

EXPERIMENTAL

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

Drug: Epalrestat,Mecobalamin

The control group

EXPERIMENTAL

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

Drug: Mecobalamin

Interventions

Epalrestat,Mecobalamin 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.

Epalrestat

Mecobalamin DRUG

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

The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

epalrestat; mecobalamin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 11, 2022

Record last verified: 2021-10

Locations

CN (1)