1 型糖尿病微血管功能障碍的治疗策略 (KML002)
2023年11月3日 更新者:Kaitlin Love, MD、University of Virginia
研究人员将检验这样一个假设,即在患有 1 型糖尿病 (T1D) 的成人中,胰高血糖素样肽-1 受体激动剂(GLP-1RA,即度拉糖肽)和运动训练均通过减弱内皮氧化作用增强胰岛素介导的骨骼肌微血管灌注压力,从而改善内皮功能。
研究概览
详细说明
在这项研究中,64 名(n=42 需要完成)成年 1 型糖尿病参与者将被随机分配 (1:1:1) 接受 3 种干预措施中的一种,为期 14 周:1) dulaglutide,2) 安慰剂,或 3)运动训练。
参与者将在基线和 14 周时接受两次研究入院。 每次入院前,参与者将佩戴连续血糖监测仪 (Dexcom G6 Professional) 10 天以评估血糖变异性 (GV)。 入院前,他们将接受心肺健康测试。 在研究入院日,参与者将在开始血管测试之前接受肘前静脉内皮细胞活检。 从收获的内皮细胞中,研究人员将量化与胰岛素介导的内皮功能相关的内皮细胞活性氧 (ROS) 和蛋白质表达。 血管测试将包括股四头肌的造影增强超声以确定微血管血容量 (MBV)。 研究人员还将测量肱动脉血流介导的扩张 (FMD)。 股四头肌骨骼肌氧合 (HHb) 也将被测量。 这些血管和肌肉氧合测量将在 120 分钟的正常血糖胰岛素钳夹前后进行,该钳夹将根据葡萄糖输注率 (GIR) 测量胰岛素敏感性。
这项随机、安慰剂对照研究将评估 GLP-1 受体激动剂与度拉糖肽或运动训练是否能改善胰岛素介导的骨骼肌微血管灌注。 研究人员将评估微血管灌注与心肺适能 (VO2max)、胰岛素敏感性 (GIR)、内皮活性氧 (ROS) 和血糖变异性 (GV) 之间的预测关系。
研究类型
介入性
注册 (估计的)
64
阶段
- 阶段2
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。
学习联系方式
- 姓名:Kaitlin Love, MD
- 电话号码:434-924-9651
- 邮箱:KML2W@hscmail.mcc.virginia.edu
研究联系人备份
- 姓名:Lee Hartline, MEd
- 邮箱:lmh9d@virginia.edu
学习地点
-
-
Virginia
-
Charlottesville、Virginia、美国、22908
- 招聘中
- University of Virginia
-
接触:
- Kaitlin Love, MD
- 邮箱:KML2W@hscmail.mcc.virginia.edu
-
-
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
18年 至 40年 (成人)
接受健康志愿者
不
描述
纳入标准:
- 1 型糖尿病病史,持续时间 > 5 年
- 年龄 18-40 岁
- 糖化血红蛋白 < 8.5%
- 体重指数 19-27 公斤/平方米
- 仅将胰岛素用于糖尿病治疗(每日多次注射或使用或不使用传感器增强的胰岛素泵)
- 在过去的 6 个月中使用稳定的非糖尿病药物治疗方案
- 所有筛查实验室均在正常范围内或无临床意义
- C 肽 <0.6 纳克/毫升
- 每周进行少于 150 分钟的中等强度体育活动或少于 70 分钟的高强度体育活动(即 达到比美国糖尿病协会推荐的更少的体力活动)
排除标准:
- 怀孕或目前正在哺乳
- 6个月内吸烟史
- 微血管(微量白蛋白尿、视网膜病变、神经病变)或大血管糖尿病并发症(冠状动脉疾病、中风、外周血管疾病)以及有临床意义的心律失常或传导障碍的病史
- 服用血管活性药物(即 钙通道阻滞剂、血管紧张素转换酶或肾素抑制剂、血管紧张素受体阻滞剂、硝酸盐、α-受体阻滞剂)。
- 已知对 perflutren 过敏(包含在 Definity© contrast 中)
- 筛查 O2 饱和度 <90%
- 肌肉骨骼状况妨碍参与运动测试或运动训练
- 除 T1D 以外的急性或不稳定疾病
- 低血糖无意识(基于 Clarke 问卷)
- 胃轻瘫、严重胃食管反流、胰腺炎、甲状腺髓样癌或多发性内分泌肿瘤 2 型个人或家族史
- 贫血(女性血红蛋白 <12 g/dL,男性血红蛋白 <13 g/dL),嗜酸性粒细胞增多(嗜酸性粒细胞绝对计数 >500 个细胞/微升),白细胞减少症(白细胞总数 <4,000 个细胞/微升)
- 糖尿病酮症酸中毒 (DKA) 在筛选访视或研究入院日时出现
- 1 年内因 DKA 入院
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:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
生理盐水皮下注射,体积与度拉鲁肽相匹配,即每周 0.5 mL,持续 14 周
|
生理盐水安慰剂
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有源比较器:度拉糖肽
Dulaglutide(每周 0.75 mg/0.5 mL,持续 2 周,然后每周 1.5 mg/0.5 mL,持续 12 周)皮下注射
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GLP1-RA
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有源比较器:运动训练
固定自行车上的监督高强度间歇训练将每周进行 3 天,持续 14 周。
参与者将以低强度热身 3 分钟,然后重复 1 分钟的 100% 峰值功率输出,然后以 50 W 恢复 1 分钟。训练将从每次训练 6 个间隔开始,每 2 周增加 2 个间隔。
会议将以 10 分钟的冷却时间结束。
|
有监督的高强度间歇训练
|
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 |
---|---|---|
微血管血容量 (MBV)
大体时间:在基线和治疗 14 周后。
|
胰岛素介导的肌肉微血管血容量 (MBV) 的变化。
微血管一氧化氮依赖性内皮功能的测量
|
在基线和治疗 14 周后。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
肱动脉血流介导的扩张 (FMD)
大体时间:在基线和治疗 14 周后
|
后闭塞百分比 (%) 直径变化。
导管动脉一氧化氮依赖性内皮功能的测量。
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在基线和治疗 14 周后
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葡萄糖输注率 (GIR)
大体时间:在基线和治疗 14 周后
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正常血糖胰岛素钳夹最后 30 分钟的平均 GIR;胰岛素敏感性的量度
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在基线和治疗 14 周后
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心肺适能,最大耗氧量 (VO2max)
大体时间:在基线和治疗 14 周后
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通过自行车测力计运动测试进行评估。
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在基线和治疗 14 周后
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骨骼肌氧合作用,脱氧血红蛋白 (HHb)
大体时间:在基线和治疗 14 周后。在胰岛素钳夹前后测量。
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通过股四头肌的频域多距离近红外光谱 (NIRS) 监测仪进行评估
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在基线和治疗 14 周后。在胰岛素钳夹前后测量。
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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
- 首席研究员:Kaitlin Love, MD、Associate Professor - Endocrinology
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)
2023年10月5日
初级完成 (估计的)
2027年11月30日
研究完成 (估计的)
2027年11月30日
研究注册日期
首次提交
2022年7月25日
首先提交符合 QC 标准的
2022年7月25日
首次发布 (实际的)
2022年7月28日
研究记录更新
最后更新发布 (实际的)
2023年11月7日
上次提交的符合 QC 标准的更新
2023年11月3日
最后验证
2023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.
糖尿病,1 型的临床试验
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的