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

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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Drug: Epalrestat,Mecobalamin; Drug: Mecobalamin

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epalrestat; oral epalrestat (50mg/ time, 3 times/day) + conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year	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.
Experimental: The control group; conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year	Drug: Mecobalamin; Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Micronutrients; Vitamins; Vitamin B Complex; Vitamin B 12; Epalrestat
• Other Study ID Numbers: 20210406

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No