Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes (ZQL010)
2026年5月1日 更新者：Zhenqi Liu、University of Virginia
Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes (
The purpose of this study is:
- To see if insulin resistance (how sensitive your muscle tissue is to insulin) is associated with lower cardio fitness in people with Type 1 diabetes compared to healthy controls, before and after a High Intensity Interval Training (HIIT) exercise program.
- To see if being overweight and having Type 1 diabetes is associated with lower cardio fitness compared to overweight healthy controls, before and after a HIIT exercise program.
研究概览
详细说明
This study will test the hypothesis that in humans with T1D skeletal muscle microvascular insulin resistance predicts a reduction in Cardiorespiratory Fitness (CRF) and obesity exacerbates microvascular insulin resistance, leading to further CRF decline, which is mechanistically linked to increased muscle microvascular endothelial oxidative stress, impaired muscle mitochondrial function, reduced muscle capillary density and decreased satellite cells.
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
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：Lee Hartline, MEd
- 电话号码：434-924-5247
- 邮箱：lmh9d@virginia.edu
研究联系人备份
- 姓名：Zhenqi Liu, MD
- 邮箱：zl3e@UVAhealth.org
学习地点
-
-
Virginia
-
Charlottesville、Virginia、美国、22908
- 招聘中
- University of Virginia
-
首席研究员：
- Zhenqi Liu, MD
-
接触：
- Lee Hartline, MEd
- 电话号码：434-924-5247
- 邮箱：lmh9d@virginia.edu
-
接触：
- Zhenqi Liu, MD
- 电话号码：434-924-5247
- 邮箱：zl3e@UVAhealth.org
-
-
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
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
• Male or female ≥21 and ≤50 years old
- For persons with T1D: Disease duration ≥ 5 years and HbA1c ≤ 8.5% on multiple daily insulin injection or insulin pump
- Body mass index: ≥19 and ≤27 kg/m2 for control and T1D, ≥30 and ≤40 kg/m2 (27.5 to 37.5 for Asian Americans) for obesity and T1D + obesity. BMI is limited to ≤40 kg/m2 (37.5 for Asian Americans) for easier vascular access and cardiac imaging.
- Stable use of non-insulin medications for over 6 months other than estrogen/progesterone containing medications which must be discontinued at least 3 months prior to the study (intrauterine devices may be continued due to limited systemic absorption)
Exclusion Criteria:
• Acute or chronic disease other than T1D or obesity
- History of microvascular or macrovascular diabetes complications
- History of diabetic ketoacidosis in the past 24 months
- History of hypoglycemia unawareness
- Recently active (>20 min of moderate/high intensity exercise, 2 times/week)
- Subjects who are smokers or who have quit smoking <5 years
- Subjects with hypertriglyceridemia (>400 mg/dl)
- Current use of vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha- or beta-blockers, or diuretics).
- Females taking oral contraceptives in the past 3 months
- Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy
- Pregnant (as evidenced by positive pregnancy test) or nursing women
- Musculoskeletal condition preventing participation in exercise testing or exercise training
- History of gastroparesis
- Pulse oximetry <90%
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：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 |
|---|---|
|
有源比较器：Type 1 diabetes - normal weight
Type 1 diabetes normal weight
|
15 weeks of HIIT exercise training
|
|
有源比较器：Control - normal weight
healthy control - normal weight
|
15 weeks of HIIT exercise training
|
|
有源比较器：Overweight control
Overweight, otherwise healthy
|
15 weeks of HIIT exercise training
|
|
有源比较器：Type 1 diabetes - overweight
|
15 weeks of HIIT exercise training
|
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 |
|---|---|---|
|
Microvascular blood volume in skeletal and cardiac muscle - changes from baseline
大体时间：Before and after 15 weeks of exercise training
|
insulin-mediated changes in skeletal and cardiac muscle as determined by insulin clamp
|
Before and after 15 weeks of exercise training
|
|
maximal aerobic exercise capacity
大体时间：before and after 15 weeks of exercise training
|
change in VO2max
|
before and after 15 weeks of exercise training
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
insulin-mediated whole body glucose disposal
大体时间：before and after 15 weeks of exercise training
|
insulin-mediated whole body glucose disposal during insulin clamp
|
before and after 15 weeks of exercise training
|
|
Muscle capillary density and satellite cells
大体时间：before and after 15 weeks of exercise training
|
Changes in muscle capillary density and satellite cells
|
before and after 15 weeks of exercise training
|
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：Zhenqi Liu, MD、University of Virginia
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)
2026年2月23日
初级完成 (估计的)
2030年6月30日
研究完成 (估计的)
2030年6月30日
研究注册日期
首次提交
2026年4月14日
首先提交符合 QC 标准的
2026年5月1日
首次发布 (实际的)
2026年5月7日
研究记录更新
最后更新发布 (实际的)
2026年5月7日
上次提交的符合 QC 标准的更新
2026年5月1日
最后验证
2026年5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.