Clinical trial NCT05184049: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of resting-state functional Magnetic Resonance Imaging
timeFrame: baseline , 6months
Secondary outcomes:
measure: Mean change of electromyography
timeFrame: baseline , 6months
measure: Mean change of quantitative somatosensory testing
timeFrame: baseline , 6months
measure: Mean change of corneal confocal focus
timeFrame: baseline , 6months
measure: Mean change in HbA1c
timeFrame: baseline , 6months
measure: Change of Self-Rating Anxiety Scale
timeFrame: baseline , 6months
measure: Change of Self-Rating Depression Scale
timeFrame: baseline , 6months
measure: Mean change of Toronto clinical scoring system
timeFrame: baseline , 6months
measure: Mean change of Neuropathic pain scale
timeFrame: baseline , 6months
measure: Mean change of Michigan neuropathy screening form
timeFrame: baseline , 6months
measure: Mean change of mini-mental state examination
timeFrame: baseline , 6months
measure: Mean change of Montreal Cognitive Assessment
timeFrame: baseline , 6months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: