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

Phase 4

• Conditions: Diabetes
• Interventions: Drug: Epalrestat,Mecobalamin; Drug: Mecobalamin

• Registration Number: NCT05184049
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-11-02
• Study Start: 2022-01
• Study First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epalrestat	Epalrestat,Mecobalamin	oral epalrestat (50mg/ time, 3 times/day) + conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year
The control group	Mecobalamin	conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year

Primary Outcome Measures

Name	Time	Method
The change of resting-state functional Magnetic Resonance Imaging	baseline , 6months	The change in grey matter volume,white matter area, local gyrification index after 6-months treatment

Secondary Outcome Measures

Name	Time	Method
Mean change of quantitative somatosensory testing	baseline , 6months	Mean change of temperature perception threshold(℃) after 6-months treatment
Change of Self-Rating Anxiety Scale	baseline , 6months	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.
Mean change of mini-mental state examination	baseline , 6months	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.
Mean change in HbA1c	baseline , 6months	Mean change of HbA1c(%) after 6-months treatment
Mean change of corneal confocal focus	baseline , 6months	Mean change of nerve fibre density(no./mm2) after 6-months treatment
Mean change of Montreal Cognitive Assessment	baseline , 6months	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.
Mean change of electromyography	baseline , 6months	mean change from baseline in nerve conduction velocity(m/s) after 6-months treatment
Mean change of Toronto clinical scoring system	baseline , 6months	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.
Mean change of Michigan neuropathy screening form	baseline , 6months	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.
Change of Self-Rating Depression Scale	baseline , 6months	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.
Mean change of Neuropathic pain scale	baseline , 6months	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.

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China