用于评估胰岛素抵抗的胰岛素钳辅助研究
2017年3月10日 更新者：Jaeb Center for Health Research
超重青少年 1 型糖尿病 (T1D) 的二甲双胍治疗——用于评估胰岛素抵抗的胰岛素钳夹辅助研究
用于评估胰岛素抵抗的胰岛素钳辅助研究将作为主要方案的子研究进行，二甲双胍治疗超重青少年 1 型糖尿病 (NCT01881828)。
这项辅助研究的目的是评估二甲双胍是否会使用高胰岛素正常血糖钳夹改善 1 型糖尿病的组织特异性胰岛素抵抗 (IR)；一项为期 3 个月的随机试验，比较二甲双胍与安慰剂在 12 至 <20 岁且 BMI >85% 的人群（每日总胰岛素剂量 >0.7 单位/千克，HbA1c 7.0%-9.9%）。
研究概览
研究类型
介入性
注册 (实际的)
37
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Florida
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Tampa、Florida、美国、33647
- Jaeb Center for Health Research
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 至 19年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
1. 符合主要研究的资格标准，二甲双胍治疗超重青少年 1 型糖尿病 (NCT01881828)。
排除标准：
1. 低血红蛋白或血细胞比容，如每个当地机构的胰岛素钳夹规则所定义，或者如果没有机构要求，则血细胞比容 <30% 或血红蛋白 <10 gm/dL
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：二甲双胍
二甲双胍 2000 毫克/天
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每片的强度为 500 毫克。
参与者将在 4 周内增加每日剂量，每天服用 1 片，连续 7 天，每天 2 次，每次 1 片，连续 7 天，早上 1 片，晚上 2 片，连续 7 天，然后早上 2 片晚上 2 片，在剩余的研究治疗期间每天服用。
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安慰剂比较：口服安慰剂
中央药房将配制安慰剂以匹配二甲双胍药片。 安慰剂产品将包含以下成分：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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胰岛素抵抗 (IR) 从基线到 13 周的变化
大体时间：0-13周
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高胰岛素正常血糖钳夹通过葡萄糖输注率 (GIR) 评估二甲双胍对肌肉 IR 的影响。
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0-13周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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肝脏 IR 从基线到 13 周的变化
大体时间：0-13周
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使用葡萄糖和甘油同位素的分级高胰岛素正常血糖钳夹以评估二甲双胍对以下方面的影响： • 肝脏红外 |
0-13周
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脂肪 IR 从基线到 13 周的变化
大体时间：0-13周
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使用葡萄糖和甘油同位素的分级高胰岛素正常血糖钳夹以评估二甲双胍对以下方面的影响： • 脂肪红外线 |
0-13周
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Ingrid Libman, MD, PhD、Childrens Hospital of University of Pittsburgh Medical Center
- 学习椅：Kristen Nadeau, MD、University of Colorado Denver/Childrens Hospital Colorado
- 首席研究员：Kellee M Miller, MPH、Jaeb Center for Health Research
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (实际的)
2016年2月15日
研究完成 (实际的)
2016年2月15日
研究注册日期
首次提交
2014年1月15日
首先提交符合 QC 标准的
2014年1月22日
首次发布 (估计)
2014年1月24日
研究记录更新
最后更新发布 (实际的)
2017年3月14日
上次提交的符合 QC 标准的更新
2017年3月10日
最后验证
2017年3月1日
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.