The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- the severity of diabetic peripheral neuropathy
研究概览
简要总结
The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy.
详细描述
This is a multi-center(about five), randomized, double-blind, placebo-controlled clinical trial with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University(KY-2022-R009).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who had undergone nerve conduction examination by electromyography(EMG).
排除标准
- •pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections;
- •patients with alcohol abuse; history of Autoimmune liver disease, liver disease or abnormal liver function at baseline;
- •parathyroid diseases (including hyperthyroidism and hypothyroidism);
- •pancreatitis, pancreatectomy or any transplant;
- •patients with malignancy and any serious concomitant disease limit the existence of life expectancy
研究组 & 干预措施
diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.
Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.
干预措施: hypoglycemic Agents(metformin) (Drug)
diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.
Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.
干预措施: lipid-lowering drug(Statin) (Drug)
Diabetic group with hypoglycemic or lipid-lowering drugs.
Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group with hypoglycemic or lipid-lowering drugs group. group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.
干预措施: hypoglycemic Agents(metformin) (Drug)
Diabetic group with hypoglycemic or lipid-lowering drugs.
Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group with hypoglycemic or lipid-lowering drugs group. group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.
干预措施: lipid-lowering drug(Statin) (Drug)
结局指标
主要结局
the severity of diabetic peripheral neuropathy
时间窗: From admission to discharge, up to 1 week
The nerve conduction examination was conducted at a room temperature of 24℃, with the legs warmed using an electric heating pad for at least 10 minutes to achieve a skin temperature of 32-35℃. The nerve conduction velocities and nerve conduction amplitudes were measured for both sides of the upper and lower limbs, including motor and sensory branches of the median nerve; motor and sensory branches of the ulnar nerve; motor branch of peroneal nerve; motor branch of the tibial nerve; sensory branch of the superficial peroneal nerve. In addition, both sides of the tibial nerve F-wave were recorded, and the lower one was regarded as the final F-wave. Slowed/blocked nerve conduction was defined as more than 2.5 standard deviation below the control nerve conduction threshold. Nerve conduction is defined as abnormal when two or more nerve abnormalities are detected.
the presence of diabetic peripheral neuropathy
时间窗: From admission to discharge, up to 1 week
When any of the elements of the screening process -- symptoms, signs, or abnormal nerve conduction parameters --was abnormal, medical records would be scrutinized to see if these participants had accepted a previous diabetic peripheral neuropathy diagnosis by a specialist.
次要结局
未报告次要终点