Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes (HYPO-HEART)
30 ottobre 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
42
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Hellerup, Danimarca, 2900
- Gentofte Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patiens with insulin-treated type 2 diabetes with complications and healthy controls
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Controlli sani
Soggetti di controllo sani
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Part 1: Clinically relevant arrhythmias
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Part 1: Differences in mean corrected QT interval (QTc)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 febbraio 2017
Completamento primario (Effettivo)
6 gennaio 2020
Completamento dello studio (Effettivo)
6 gennaio 2020
Date di iscrizione allo studio
Primo inviato
25 aprile 2017
Primo inviato che soddisfa i criteri di controllo qualità
10 maggio 2017
Primo Inserito (Effettivo)
11 maggio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 novembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- H-16046212
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .