Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes (HYPO-HEART)
2020年10月30日 更新者：Andreas Andersen、University Hospital, Gentofte, Copenhagen
Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along with a control group of twenty-one individuals with normal glucose tolerance matched for age, gender, and body mass index.
Patients with type 2 diabetes will be scheduled for a three-week run-in period with LR and CGM prior to participation in Part 1.
Only patients with a well-functioning loop-recorder and who can comply with CGM will be included.
Patients with type 2 diabetes will continue in part 2 of the study, a one year observational study employing CGM and LR and clinical examination after 1, 3, 6, 9, and 12 months and an extended observation period of 2 years employing LR and clinical examination.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
42
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
-
-
-
Hellerup、丹麦、2900
- Gentofte Hospital
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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
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patiens with insulin-treated type 2 diabetes with complications and healthy controls
描述
Inclusion Criteria:
Patients with type 2 diabetes
- Informed and written consent
- Type 2 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- Treatment with insulin
- Glycated haemoglobin A1c (HbA1c) ≤58 mmol/mol
- One or more clinical relevant complications to diabetes defined as: peripheral neuropathy with vibration perception threshold of > 25 volt determined by biothesiometry, moderate to severe retinopathy, nephropathy (creatinine >130 μmol/l and/or albuminuria), and/or macrovascular disease. Macrovascular disease is defined as coronary disease (stable angina pectoris or previous unstable angina pectoris or myocardial infarct), cerebrovascular disease (previous stroke or transitional cerebral ischaemia), and peripheral vascular disease (previous intermittent claudication or prior acute ischemia)
- Well-functioning LR during run-in period (acceptable readings judged by an arrhythmologist)
- Participation in the extended study
Healthy individuals
- HbA1c ≤42 mmol/mol
- Fasting plasma glucose ≤6.1 mmol/l
Exclusion Criteria:
Patients with type 2 diabetes
- Arrhythmia diagnosed prior to or at the time of inclusion
- Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
- Severe heart failure (left ventricular ejection fraction <25%)
- Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- Insulin naïve patients with type 2 diabetes
- Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
- Unable to comply with daily CGM during run-in period
- Anemia (male: hemoglobin < 8.0; female: hemoglobin < 7.0 mmol/l)
Healthy individuals
- Type 1 or type 2 diabetes
- Prediabetes (HbA1c >42 mmol/l and/or fasting plasma glucose >6.1 mmol/l)
- Family history of diabetes (type 1 og type 2 diabetes)
- Arrhythmia diagnosed prior to or at the time of inclusion
- ICD or pacemaker at the time of inclusion
- Severe heart failure (left ventricular ejection fraction <25%)
- Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
- Anemia (male: hemoglobin < 8.0; female: hemoglobin < 7.0 mmol/l)
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Patients with type 2 diabetes
Insulin-treated type 2 diabetes with diabetic complications
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During the entire clamp, participants will be monitored by ECG, pulse oximetry, and blood pressure and plasma glucose will be measured bedside every fifth minute.
Additionally, patients with type 2 diabetes will be monitored by a loop recorder (LR) and a continuous glucose monitor (CGM).
Comparison of LR and CGM recordings with the recordings obtained by ECG Holter monitor and blood sampling will be used for validation of the method used in Part 2 of the study.
Blood samples will be drawn and analysed for changes in electrolytes, insulin, glucagon, catecholamines and cortisone.
A cardiac haemodynamic evaluation will be performed by echocardiography at baseline, hyperglycaemia, and hypoglycaemia.
Implantation of a loop-recorder
Monitoring with a continuous glucose monitor
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健康控制
健康对照对象
|
During the entire clamp, participants will be monitored by ECG, pulse oximetry, and blood pressure and plasma glucose will be measured bedside every fifth minute.
Additionally, patients with type 2 diabetes will be monitored by a loop recorder (LR) and a continuous glucose monitor (CGM).
Comparison of LR and CGM recordings with the recordings obtained by ECG Holter monitor and blood sampling will be used for validation of the method used in Part 2 of the study.
Blood samples will be drawn and analysed for changes in electrolytes, insulin, glucagon, catecholamines and cortisone.
A cardiac haemodynamic evaluation will be performed by echocardiography at baseline, hyperglycaemia, and hypoglycaemia.
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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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Part 1: Clinically relevant arrhythmias
大体时间：0-240 min during the combined hyper- and hypoglycaemic clamp
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Composite endpoint including atrial fibrillation, brady-arrhythmias and tachy-arrhythmias.
Clinically relevant brady-arrhythmias are defined as sinus arrest for more than 3 seconds, frequency below 30 beats per minute (bpm), or high grade atrioventricular (AV) block including Mobitz Type II and third-degree AV block.
Clinically relevant tachy-arrhythmias are defined as sustained ventricular tachycardia (duration >30 seconds), and non-sustained ventricular tachycardia.
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0-240 min during the combined hyper- and hypoglycaemic clamp
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Part 2: Prevalence of clinically relevant arrhythmias as defined above
大体时间：Within 12 months
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Prevalence of clinically relevant arrhythmias as defined above
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Within 12 months
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Part 2: Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia
大体时间：Within 12 months
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Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia
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Within 12 months
|
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Part 2: Difference in MAGE
大体时间：Within 12 months
|
Difference in mean amplitude of glycaemic excursions (MAGE) two hours preceding an arrhythmic event versus MAGE during non-event
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Within 12 months
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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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Part 1: Differences in mean corrected QT interval (QTc)
大体时间：0-240 min during the combined hyper- and hypoglycaemic clamp
|
Differences in mean corrected QT interval (QTc) between patients with type 2 diabetes and matched normal glucose tolerant individuals during the combined hyper- and hypoglycaemic clamp
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0-240 min during the combined hyper- and hypoglycaemic clamp
|
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Part 1: Difference in counter regulatory hormonal response
大体时间：0-240 min during the combined hyper- and hypoglycaemic clamp
|
Difference in counter regulatory hormonal response between patients with type 2 diabetes and matched normal glucose tolerant individuals during the combined hyper- and hypoglycaemic clamp
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0-240 min during the combined hyper- and hypoglycaemic clamp
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Part 1: Differences in haemodynamic regulation
大体时间：0-240 min during the combined hyper- and hypoglycaemic clamp
|
Differences in haemodynamic regulation (measured by echocardiography) between patients with type 2 diabetes and matched normal glucose tolerant individuals during a combined hyper- and hypoglycaemic clamp
|
0-240 min during the combined hyper- and hypoglycaemic clamp
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Part 2: Clinical relevant arrhythmias during low glucose variability compared to high glucose variability.
大体时间：Within 12 months
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Clinical relevant arrhythmias during low glucose variability (LGV), defined as variations in plasma glucose below or equal to 5 mmol/l within two hours preceding an arrhythmic event, compared to high glucose variability (HGV), defined as variations in plasma glucose above 5 mmol/l within two hours preceding an arrhythmic event
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Within 12 months
|
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Part 2: The relationship between cardiovascular disease at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
大体时间：Within 12 months
|
The relationship between cardiovascular disease (heart failure and ischaemic heart disease) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
|
Within 12 months
|
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Part 2: The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
大体时间：Within 12 months
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The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
|
Within 12 months
|
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Part 2: The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
大体时间：Within 12 months
|
The relationship between diabetes complication status (neuropathy, nephropathy, retinopathy) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
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Within 12 months
|
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Part 2: Correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias
大体时间：Within 12 months
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Correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias
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Within 12 months
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Part 2: Correlation between plasma glucose variation and risk of clinical relevant arrhythmias
大体时间：Within 12 months
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Correlation between plasma glucose variation (variation in plasma glucose (Δ mmol/l) within two hours of the event) and risk of clinical relevant arrhythmias
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Within 12 months
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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。
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。
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2月1日
初级完成 (实际的)
2020年1月6日
研究完成 (实际的)
2020年1月6日
研究注册日期
首次提交
2017年4月25日
首先提交符合 QC 标准的
2017年5月10日
首次发布 (实际的)
2017年5月11日
研究记录更新
最后更新发布 (实际的)
2020年11月2日
上次提交的符合 QC 标准的更新
2020年10月30日
最后验证
2020年10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.