Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus
研究概览
详细说明
Objective: Although high doses of cyclosporin (cyclo) inhibits the development of type 1 diabetes mellitus, its usefulness is limited by its toxicity. Since methotrexate (mtx) and cyclo synergistically inhibit other disease processes, we hypothesized that low dose cyclo and mtx therapy could safely induce remission.
Research Design and Methods: In an open pilot study, insulin dose and glycemic control will be compared in children with new onset Type 1 diabetes administered cyclo at 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day and mtx 5 mg/kg/day for one year with control children. After 6 weeks, doses were adjusted to maintain blood cyclo levels to 100-200 ng/ml.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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District of Columbia
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Washington DC、District of Columbia、美国、20007
- Georgetown University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of Type1 diabetes mellitus and be obtaining insulin therapy for less than 4 weeks
Exclusion Criteria:
- Ketoacidosis
- Body weight over 110% of ideal weight
- Condition where immunosuppression is contraindicated
- Abnormal liver or renal function tests
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:cyclosporin+Methotrexate
cyclosporin treatment at 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for on year and methotrexate 5 mg/kg/day for one year.
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cyclosporin 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for one year and methotrexate 5 mg/kg/day for one year.
After 6 weeks, cyclosporin doses will adjusted to maintain blood cyclo levels to 100-200 ng/ml.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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insulin dose
大体时间:one year
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one year
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次要结果测量
结果测量 |
大体时间 |
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renal function
大体时间:one year
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one year
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合作者和调查者
调查人员
- 首席研究员:Douglas Sobel, MD、Georgetown University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
1 型糖尿病的临床试验
cyclosporin and methotrexate的临床试验
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USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis Obispo完全的
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Sykehuset Asker og BaerumUllevaal University Hospital完全的
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University of British ColumbiaSocial Sciences and Humanities Research Council of Canada完全的
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Dana-Farber Cancer Institute邀请报名