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

January 7, 2022 updated by: Xiangya Hospital of Central South University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change of resting-state functional Magnetic Resonance Imaging
Time Frame: baseline , 6months
The change in grey matter volume,white matter area, local gyrification index after 6-months treatment
baseline , 6months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change of electromyography
Time Frame: baseline , 6months
mean change from baseline in nerve conduction velocity(m/s) after 6-months treatment
baseline , 6months
Mean change of quantitative somatosensory testing
Time Frame: baseline , 6months
Mean change of temperature perception threshold(℃) after 6-months treatment
baseline , 6months
Mean change of corneal confocal focus
Time Frame: baseline , 6months
Mean change of nerve fibre density(no./mm2) after 6-months treatment
baseline , 6months
Mean change in HbA1c
Time Frame: baseline , 6months
Mean change of HbA1c(%) after 6-months treatment
baseline , 6months
Change of Self-Rating Anxiety Scale
Time Frame: 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.
baseline , 6months
Change of Self-Rating Depression Scale
Time Frame: 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.
baseline , 6months
Mean change of Toronto clinical scoring system
Time Frame: 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.
baseline , 6months
Mean change of Neuropathic pain scale
Time Frame: 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.
baseline , 6months
Mean change of Michigan neuropathy screening form
Time Frame: 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.
baseline , 6months
Mean change of mini-mental state examination
Time Frame: 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.
baseline , 6months
Mean change of Montreal Cognitive Assessment
Time Frame: 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.
baseline , 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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