JPRN-UMIN000020876尚未招募未知
The investigation of norepinephrine/serotonin transporter in patients with painful diabetic neuropathy
ational Institute of Radiological Sciences0 个研究点目标入组 26 人开始时间: 2016年2月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- •Diabetic neuropathy
- •Patients who were diagnosed type 2 diabetes mellitus
- •?Patients complaining of neuropathic pain in the bilateral feet ( not includes only symptom of arms, coldness).
- •?Patients excluded other diagnoses which cause neuropathic pain.
- •?Patients with more than one month duration of symptom.
- •?Patients who understand written informed consent.
- •Healthy individuals
- •?Persons with no history of mental diseases.
- •?Persons with no history of diabete mellitus and other serious physical diseases.
- •?Persons who understand written informed consent.
排除标准
- •Diabetic neuropathy
- •?Patients taking pregabalin, carbamazepine, mexiletine within a weeks from registration.
- •?Patients taking monoamine oxidase inhibitor within two weeks from registration.
- •?Patients who showed a significant glycemic improvement by the treatment within four weeks from registration.
- •?Patients who are likely to experience significant glycemic improvement during the test period.
- •?Patients who are likely to require hospitalizations due to poor glycemic control.
- •?Patients with the involvement of alcoholic neuropathy.
- •?Patients with history of drug abuse or addiction.
- •?Patients with severe complications (cardiac failure, renal failure, hepatic failure, hemorrhagic peptic ulcers,bowel obstruction, malignant tumor, glaucoma.)
- •?Patients with pregnancy or desire to bear children.
- •?Patients with allergic history to duloxetine
- •?Patients who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, etc).
- •?Patients with strong claustrophobia
- •?Patients with history of treatment to depression, bipolar disorder, anxiety disorder, anorexia nervosa within one year prior to the registration.
- •?Patients corresponding to both of PHQ-2, or PHQ-9 score >15.
- •Patients considered inappropriate by investigators
- •Healthy individuals
- •?Persons with pregnancy or desire to bear children.
- •?Persons who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, etc).
- •?Persons with strong claustrophobia
- •?Patients within 6 months after the last injection of radioisotopes
- •?Patients considered inappropriate by investigators
研究者
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