不同胰岛素类似物对 1 型糖尿病患者氧化应激的影响。 （Ineox 研究） (INEOX)
2021年11月23日 更新者：Virginia Morillas、Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
不同胰岛素类似物对 1 型糖尿病患者氧化应激的影响。低水平干预的临床试验。 （Ineox 研究）
本研究在一组 DM 1 患者中评估了不同电流胰岛素类似物治疗对氧化应激参数的影响
研究概览
详细说明
通过在一组 DM 1 患者中进行的随机研究，评估不同电流类似物治疗对氧化应激参数的影响
胰岛素通过分析：
- - 氧化应激标志物的循环水平：A) 抗氧化：总抗氧化能力 (CAT)，B) 氧化：8-iso-prostaglandin F2 alpha (8-iso-PGF2α)，酸反应物质硫代巴比妥酸 (TBARS) 和 LDL-氧化。
- - 分析了血糖控制变量（HbA1c 和平均血糖）和变异性（标准差 (SD)、变异系数 (CV) 和 MAGE（血糖波动的平均幅度）和氧化应激参数之间的关系。
目标 2：
研究与过程和氧化状态相关的细胞通路的激活，通过多达 50 个基因的表达阵列，这些基因编码氧化应激反应基因，如 CPT1a（肉碱棕榈酰转移酶 1a，线粒体氧化 b 限制酶），TAS（脂肪酰基合成酶)、乙酰辅酶 A 羧化酶、Acadm（中链酰基脱氢酶）、Acadl（长链酰基脱氢酶）、Acadvl（长链酰基辅酶 A 脱氢酶）、SOD1、Hmox1 和谷氨酰胺-半胱氨酸连接酶 (Gclc)。
研究类型
介入性
注册 (实际的)
300
阶段
- 第四阶段
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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Málaga、西班牙
- Regional University Hospital of Malaga
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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
16年 至 63年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 年龄在 18 岁至 65 岁（含）之间。
- DM1 在马拉加大学地区医院的糖尿病科进行了两年多的演变，并进行了习惯性随访。
- HbA1c ≤ 10%
- 在研究开始前使用基础 MDI - Bowl 强化治疗超过 12 个月。
- 给予知情同意。
排除标准：
- 慢性肾病、肝病、甲状腺功能障碍（正确治疗控制的甲减除外）。
- 怀孕或怀孕计划。
- 2型糖尿病。
- 高尿酸血症（尿酸≥7 mg / dl 在包含或当前使用别嘌醇治疗时）。
- 缺乏合作（知情同意）。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：德谷和诺和锐
接受 Tresiba 胰岛素和 NovoRapid 胰岛素治疗的患者
|
16:00 时的基础胰岛素和该基础剂量的优化，早餐前血糖目标为 80-130 mg/dl。
其他名称：
患者已经使用的超速胰岛素和剂量调整以获得餐后血糖水平 < 150 mg/dl
其他名称：
|
|
其他：Toujeo SoloStar 和 NovoRapid
使用 Toujeo SoloStar 胰岛素和 NovoRapid 胰岛素治疗的患者
|
患者已经使用的超速胰岛素和剂量调整以获得餐后血糖水平 < 150 mg/dl
其他名称：
16:00 时的基础胰岛素和该基础剂量的优化，早餐前血糖目标为 80-130 mg/dl。
其他名称：
|
|
其他：Tresiba & 优泌乐 Kwikpen
接受 Tresiba 胰岛素和 Humalog kwikpen 胰岛素治疗的患者
|
16:00 时的基础胰岛素和该基础剂量的优化，早餐前血糖目标为 80-130 mg/dl。
其他名称：
患者已经使用的超速胰岛素和剂量调整以获得餐后血糖水平 < 150 mg/dl
其他名称：
|
|
其他：Toujeo SoloStar 和 Humalog Kwikpen
使用 Toujeo SoloStar 胰岛素和 Humalog kwikpen 胰岛素治疗的患者
|
16:00 时的基础胰岛素和该基础剂量的优化，早餐前血糖目标为 80-130 mg/dl。
其他名称：
患者已经使用的超速胰岛素和剂量调整以获得餐后血糖水平 < 150 mg/dl
其他名称：
|
|
其他：特雷西巴和阿皮德拉
接受 Tresiba 胰岛素和 Apidra 胰岛素治疗的患者
|
16:00 时的基础胰岛素和该基础剂量的优化，早餐前血糖目标为 80-130 mg/dl。
其他名称：
患者已经使用的超速胰岛素和剂量调整以获得餐后血糖水平 < 150 mg/dl
其他名称：
|
|
其他：Toujeo SoloStar 和 Apidra
使用 Toujeo SoloStar 胰岛素和 Apidra 胰岛素治疗的患者
|
16:00 时的基础胰岛素和该基础剂量的优化，早餐前血糖目标为 80-130 mg/dl。
其他名称：
患者已经使用的超速胰岛素和剂量调整以获得餐后血糖水平 < 150 mg/dl
其他名称：
|
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 |
|---|---|---|
|
新的慢速胰岛素类似物的氧化应激标志物
大体时间：6个月
|
评估使用新的慢胰岛素类似物的不同治疗对氧化应激标志物循环水平的影响。
1a) 抗氧化：总抗氧化能力 (CAT)，和 1b) 氧化：8-iso-prostaglandin F2 alpha (8-iso-PGF2α)、硫代巴比妥酸反应物质 (TBARS) 和 LDL-氧化
|
6个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
糖化血红蛋白
大体时间：6个月
|
血糖控制：糖化血红蛋白
|
6个月
|
|
平均血糖
大体时间：6个月
|
血糖控制：平均血糖 (mg/dl)
|
6个月
|
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标准偏差
大体时间：6个月
|
血糖变异性：标准偏差 [SD]
|
6个月
|
|
轻度低血糖次数
大体时间：6个月
|
两周内轻度低血糖次数
|
6个月
|
|
严重低血糖次数
大体时间：6个月
|
最近6个月严重低血糖次数
|
6个月
|
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高血糖次数
大体时间：6个月
|
两周内高血糖次数> 250 mg / dl
|
6个月
|
|
酮症发作
大体时间：6个月
|
最近 6 个月内的酮症发作
|
6个月
|
|
入院人数
大体时间：6个月
|
最近 6 个月因急性糖尿病失代偿而入院的人数。
|
6个月
|
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糖尿病生活质量问卷 (DQOL)
大体时间：6个月
|
关于1型糖尿病患者生活质量的34项
|
6个月
|
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1 型糖尿病 (DM1) 患者治疗依从性量表
大体时间：6个月
|
与患者治疗依从性相关的 15 个项目
|
6个月
|
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糖尿病痛苦量表。数字数据系统
大体时间：6个月
|
关于 1 型糖尿病患者所遭受的问题和压力的 17 个项目（Polonski y col，2005）
|
6个月
|
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对低血糖的恐惧：调查问卷 FH-15
大体时间：6个月
|
15项与1型糖尿病患者对低血糖的恐惧相关
|
6个月
|
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糖尿病治疗满意度问卷（DTSQ）。
大体时间：6个月
|
治疗满意度8项
|
6个月
|
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。
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。
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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 (实际的)
2017年1月20日
初级完成 (实际的)
2020年11月30日
研究完成 (实际的)
2021年11月20日
研究注册日期
首次提交
2017年10月29日
首先提交符合 QC 标准的
2017年10月29日
首次发布 (实际的)
2017年11月1日
研究记录更新
最后更新发布 (实际的)
2021年12月6日
上次提交的符合 QC 标准的更新
2021年11月23日
最后验证
2021年11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.
1 型糖尿病的临床试验
特雷西巴的临床试验
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Second Affiliated Hospital, School of Medicine,...招聘中
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Sansum Diabetes Research InstituteNovo Nordisk A/S完全的