ISRCTN49416618已完成未知
Taurine and painful diabetic neuropathy
niversity of Birmingham (UK)0 个研究点目标入组 180 人开始时间: 2008年3月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 180
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
- 性别
- All
入选标准
- •1. Type 1 or type 2 diabetes as defined by the World Health Organization Classification
- •2. Duration of diabetes of at least 5 years
- •3. The HbA1c should be <10.5% with <1% fluctuation of HbA1c levels over the past 6 months
- •4. Age between 18 and 80 years
- •5. Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation in the study
- •6. Must meet the specified criteria for painful DN and have no risk factors for other causes for neuropathy
- •7. Willingness to sign the Center for Research Ethics Committee (COREC) approved informed consent form
排除标准
- •1. Nursing mothers, pregnant women (excluded by a negative pregnancy test)
- •2. Patients with a history of drug or alcohol dependence in the last 5 years
- •3. Patients with pre-existing cardiovascular disease
- •4. Patients with hypoxemic disease
- •5. Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy or severe chronic pain
- •6. Patients with symptoms of neuropathic pain in the upper limbs alone
- •7. Significant changes in skin conditions in the areas to be tested which could alter sensation
- •8. Subjects with a previous history of neuropathic foot ulceration or Charcot arthropathy
- •10. Patients currently taking medications that could affect symptoms of painful DN except paracetamol (up to 4 g/d) or aspirin (up to 325 mg/d)
- •11. Patients experiencing an increase in pain after analgesic medication washout to levels which would, in the view of the PI, require prohibited analgesic therapy within a 12 week period
- •12. Patients whose creatinine clearance is less than 70 ml/min or have significant hepatic disease (Aspartate aminotransferase [AST], alanine aminotransferase [ALT], y-GT >2 times upper limit of normal)
- •13. Patients with thyroid stimulating hormone (TSH) outside normal limits
- •14. Patients with a history of previous kidney, pancreas or cardiac transplantation
- •15. Serious or unstable medical or psychological state that may interfere with study participation
- •16. Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study
- •17. Morbidly obese patients (Body Mass Index [BMI] greater than 40)
- •18. Patients who refuse to sign the informed consent
研究者
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进行中（未招募）
1 期
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