Diabetes
Conditions
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.
Interventions
DRUGEpalrestat,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.
DRUGMecobalamin
Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean change of quantitative somatosensory testing | baseline , 6months | Mean change of temperature perception threshold(℃) 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 in HbA1c | baseline , 6months | Mean change of HbA1c(%) 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. |
| 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 electromyography | baseline , 6months | mean change from baseline in nerve conduction velocity(m/s) after 6-months treatment |
| 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. |
| 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. |
| 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 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 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. |
Countries
China
Outcome results
None listed