Adverse Effects of Systemic Hypoglycemia Exposure on Endothelial Function in Humans
2017年8月10日 更新者:Medical College of Wisconsin
Prior work suggests exposure to low glucose levels (hypoglycemia) is associated with increased cardiovascular risk.
However, whether there is a causal relationship between cardiovascular events and hypoglycemia remains unclear with conflicting data in the literature.
In this study, we plan to study whether acute exposure of patients to clinically relevant (50-60 milligrams/deciliter) levels of hypoglycemia induces or worsens blood vessel endothelial dysfunction- a key 1st step in the development of heart attacks and strokes.
This will be determined in humans both with and with type 2 diabetes.
研究概览
研究类型
介入性
注册 (实际的)
5
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。
学习地点
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin
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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
21年 及以上 (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
Inclusion Criteria:
- Type 2 Diabetes Inclusion Criteria
- Adult age 21 or older
- If on 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase reductase therapy, must be on a stable dose for at least 6 weeks prior to enrollment
- Diagnosis of type 2 diabetes by a physician as defined by the American Diabetes Association standard criteria: 1) Fasting Plasma glucose at or above 126 mg/dL 2) a two-hour value in an oral glucose tolerance test at or above 200 mg/dL, or 3) a random plasma glucose concentration 200 mg/dL in the presence of symptoms, or 4) glycosylated hemoglobin greater than or equal to 6.5%.
Score of < 4 using the Gold method for assessing hypoglycemia awareness
Inclusion Criteria for Healthy subjects
- Adult age 21 or older
- No evidence of metabolic syndrome or diabetes, hypertension (BP≥140/90), or high cholesterol (LDL≥160) at the time of screen.
Exclusion Criteria:
- History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 40% on angiography or by confirmed history of myocardial infarction by standard criteria)
- Evidence of other evident major illness including chronic renal insufficiency(plasma creatinine > 1.4 for women or 1.5 for men), liver disease (aspartate aminotransferase or alanine aminotransferase greater than 2.5 x normal), and cancer currently undergoing therapy or had therapy for cancer within 1 year of enrollment.
- Pregnancy as determine by urinary pregnancy test
- Subjects on warfarin, oral anti-thrombin inhibitors, or thienopyridines
- Subjects who have had changes to dosing of thiazolidinedione, dipeptidyl peptidase-4 (DPP-4) inhibitor, or metformin therapy within 6 weeks of enrollment.
- Failed Allen's test in both arms - unable to safely place an arterial line
- Glucose reading of < 50 mg/dL and/or episodes of symptomatic hypoglycemia requiring the assistance of another person for recovery in the 2 years prior to enrollment.
- History of hypoglycemic convulsions
- Current fluoxetine therapy (known to interfere with neuroendocrine response to hypoglycemia)
- Glycosylated hemoglobin over 8.5%
- On aldosterone antagonist therapy at the time of enrollment
- On insulin therapy at the time of screening.
- History of allergy to local anesthetic injection like lidocaine.
- Age below 21.
Exclusion Criteria for Healthy Subjects:
- Meet any of the exclusion criteria for diabetic or metabolic syndrome group Meet criteria for type 2 diabetes or metabolic syndrome
- On medication for cholesterol or blood pressure.
- History of allergy to local anesthetic injection like lidocaine.
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:其他
- 分配:随机化
- 介入模型:交叉作业
- 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:Hypoglycemia First
Individuals will undergo a hyperinsulinemic hypoglycemic clamp in their 1st study visit after passing screening, and a euglycemic clamp in their second visit.
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During hypoglycemic clamping, individuals will have a blood glucose level of 50-60 mg/dL for approximately 1 hour prior to outcome measurements.
During euglycemic clamping, individuals will have a blood glucose level of 85-99 mg/dL for approximately 1 hour prior to outcome measurements.
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实验性的:Euglycemia First
Individuals will undergo a hyperinsulinemic euglycemic clamp in their 1st study visit after passing screening, and a euglycemic clamp in their second visit.
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During hypoglycemic clamping, individuals will have a blood glucose level of 50-60 mg/dL for approximately 1 hour prior to outcome measurements.
During euglycemic clamping, individuals will have a blood glucose level of 85-99 mg/dL for approximately 1 hour prior to outcome measurements.
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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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Flow induced Dilation of the Brachial Artery (FMD%)
大体时间:1 hour
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1 hour
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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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Measurement of total and phosphorylated endothelium-derived NO synthase expression in radial artery endothelial cells.
大体时间:1 hour
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1 hour
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Measurement of mitochondrial membrane potential
大体时间:1 hour
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Performed on captured radial artery endothelial cells.
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1 hour
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Mitochondrial superoxide production
大体时间:1 hour
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From capture radial artery endothelial cells.
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1 hour
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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:Michael E Widlansky, MD, MPH、Medical College of Wisconsin
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
2012年6月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2012年8月6日
首先提交符合 QC 标准的
2012年8月6日
首次发布 (估计)
2012年8月8日
研究记录更新
最后更新发布 (实际的)
2017年8月14日
上次提交的符合 QC 标准的更新
2017年8月10日
最后验证
2015年4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.
2型糖尿病的临床试验
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Jin-Hee AhnAsan Medical Center未知HER-2基因扩增 | HER-2 蛋白过表达
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Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.未知
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.主动,不招人
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AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological Pharmaceutical Co...主动,不招人
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University Hospital Inselspital, BerneUniversity of Bern; Lucerne University of Applied Sciences and Arts完全的
Glycemic clamping的临床试验
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Centre d'Etudes et de Recherche pour l'Intensification...完全的