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

Primary Purpose

Diabetes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Epalrestat,Mecobalamin
Mecobalamin
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Epalrestat

The control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2021
Last Updated
January 7, 2022
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05184049
Brief Title
Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patients
Official Title
Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patient
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epalrestat
Arm Type
Experimental
Arm Description
oral epalrestat (50mg/ time, 3 times/day) + conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year
Arm Title
The control group
Arm Type
Experimental
Arm Description
conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year
Intervention Type
Drug
Intervention Name(s)
Epalrestat,Mecobalamin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mecobalamin
Intervention Description
Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.
Primary Outcome Measure Information:
Title
The change of resting-state functional Magnetic Resonance Imaging
Description
The change in grey matter volume,white matter area, local gyrification index after 6-months treatment
Time Frame
baseline , 6months
Secondary Outcome Measure Information:
Title
Mean change of electromyography
Description
mean change from baseline in nerve conduction velocity(m/s) after 6-months treatment
Time Frame
baseline , 6months
Title
Mean change of quantitative somatosensory testing
Description
Mean change of temperature perception threshold(℃) after 6-months treatment
Time Frame
baseline , 6months
Title
Mean change of corneal confocal focus
Description
Mean change of nerve fibre density(no./mm2) after 6-months treatment
Time Frame
baseline , 6months
Title
Mean change in HbA1c
Description
Mean change of HbA1c(%) after 6-months treatment
Time Frame
baseline , 6months
Title
Change of Self-Rating Anxiety Scale
Description
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.
Time Frame
baseline , 6months
Title
Change of Self-Rating Depression Scale
Description
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.
Time Frame
baseline , 6months
Title
Mean change of Toronto clinical scoring system
Description
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.
Time Frame
baseline , 6months
Title
Mean change of Neuropathic pain scale
Description
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.
Time Frame
baseline , 6months
Title
Mean change of Michigan neuropathy screening form
Description
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.
Time Frame
baseline , 6months
Title
Mean change of mini-mental state examination
Description
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.
Time Frame
baseline , 6months
Title
Mean change of Montreal Cognitive Assessment
Description
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.
Time Frame
baseline , 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Wu
Phone
+86-13574120508
Email
wujing0731@163.com

12. IPD Sharing Statement

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

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