Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes (HYPO-HEART)
30 de outubro de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
42
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Hellerup, Dinamarca, 2900
- Gentofte Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patiens with insulin-treated type 2 diabetes with complications and healthy controls
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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Controles saudáveis
Sujeitos de controle saudáveis
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Part 1: Clinically relevant arrhythmias
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Part 1: Differences in mean corrected QT interval (QTc)
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Patrocinador
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2017
Conclusão Primária (Real)
6 de janeiro de 2020
Conclusão do estudo (Real)
6 de janeiro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
25 de abril de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de maio de 2017
Primeira postagem (Real)
11 de maio de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de novembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H-16046212
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