NCT05184049Unknown4 期
Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patient
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The change of resting-state functional Magnetic Resonance Imaging
研究概览
简要总结
This study evaluated the efficacy of epalrestat in diabetic peripheral neuropathy and its effects on the central nervous system in diabetic peripheral neuropathy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Epalrestat
Experimental
oral epalrestat (50mg/ time, 3 times/day) + conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year
干预措施: Epalrestat,Mecobalamin (Drug)
The control group
Experimental
conventional hypoglycemia + oral mecobalamin (0.5mg/ time, 3 times/day) for half a year
干预措施: Mecobalamin (Drug)
结局指标
主要结局
The change of resting-state functional Magnetic Resonance Imaging
时间窗: baseline , 6months
The change in grey matter volume,white matter area, local gyrification index after 6-months treatment
次要结局
- Mean change of quantitative somatosensory testing(baseline , 6months)
- Change of Self-Rating Anxiety Scale(baseline , 6months)
- Mean change of mini-mental state examination(baseline , 6months)
- Mean change in HbA1c(baseline , 6months)
- Mean change of corneal confocal focus(baseline , 6months)
- Mean change of Montreal Cognitive Assessment(baseline , 6months)
- Mean change of electromyography(baseline , 6months)
- Mean change of Toronto clinical scoring system(baseline , 6months)
- Mean change of Michigan neuropathy screening form(baseline , 6months)
- Change of Self-Rating Depression Scale(baseline , 6months)
- Mean change of Neuropathic pain scale(baseline , 6months)
研究者
研究点 (1)
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