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.
調査の概要
状態
完了
研究の種類
観察的
入学 (実際)
42
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Hellerup、デンマーク、2900
- Gentofte Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patiens with insulin-treated type 2 diabetes with complications and healthy controls
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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健全なコントロール
健康対照被験者
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part 1: Clinically relevant arrhythmias
時間枠：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
時間枠：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
時間枠：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
時間枠：Within 12 months
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part 1: Differences in mean corrected QT interval (QTc)
時間枠：0-240 min during the combined hyper- and hypoglycaemic clamp
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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
時間枠：0-240 min during the combined hyper- and hypoglycaemic clamp
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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
時間枠：0-240 min during the combined hyper- and hypoglycaemic clamp
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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
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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.
時間枠：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
時間枠：Within 12 months
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The relationship between cardiovascular disease (heart failure and ischaemic heart disease) 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: The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
時間枠：Within 12 months
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The relationship between pharmacological treatment 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: The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
時間枠：Within 12 months
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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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年2月1日
一次修了 (実際)
2020年1月6日
研究の完了 (実際)
2020年1月6日
試験登録日
最初に提出
2017年4月25日
QC基準を満たした最初の提出物
2017年5月10日
最初の投稿 (実際)
2017年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月2日
QC基準を満たした最後の更新が送信されました
2020年10月30日
最終確認日
2020年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。