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L'essai clinique NCT03150030 (HYPO-HEART) pour Diabète sucré de type 2, Arythmie cardiaque est terminé. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes (HYPO-HEART) 42 Observationnel
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT03150030 (HYPO-HEART) a été une étude observationnel pour Diabète sucré de type 2, Arythmie cardiaque. Son statut actuel est : terminé. L'étude a commencé le 1 février 2017, avec un objectif de recruter 42 participants. Dirigée par University Hospital, Gentofte, Copenhagen, l'étude s'est terminée le 6 janvier 2020. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 novembre 2020.
Résumé succinct
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 partic...Afficher plus
Titre officiel
Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes
Pathologies
Diabète sucré de type 2Arythmie cardiaquePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- HYPO-HEART
- H-16046212
Numéro NCT
Date de début (réel)
2017-02-01
Dernière mise à jour publiée
2020-11-02
Date de fin (estimée)
2020-01-06
Inscription (estimée)
42
Type d'étude
Observationnel
Statut
Terminé
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Patients with type 2 diabetes Insulin-treated type 2 diabetes with diabetic complications | Combined hyper- and hypoglycaemic clamp 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 validati...Afficher plus Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA) Implantation of a loop-recorder Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA) Monitoring with a continuous glucose monitor |
Healthy controls Healthy control subjects | Combined hyper- and hypoglycaemic clamp 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 validati...Afficher plus |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Part 1: Clinically relevant arrhythmias | 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. | 0-240 min during the combined hyper- and hypoglycaemic clamp |
Part 2: Prevalence of clinically relevant arrhythmias as defined above | Prevalence of clinically relevant arrhythmias as defined above | Within 12 months |
Part 2: Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia | Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia | Within 12 months |
Part 2: Difference in MAGE | Difference in mean amplitude of glycaemic excursions (MAGE) two hours preceding an arrhythmic event versus MAGE during non-event | Within 12 months |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Part 1: Differences in mean corrected QT interval (QTc) | 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 | 0-240 min during the combined hyper- and hypoglycaemic clamp |
Part 1: Difference in counter regulatory hormonal response | 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 | 0-240 min during the combined hyper- and hypoglycaemic clamp |
Part 1: Differences in haemodynamic regulation | 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 |
Part 2: Clinical relevant arrhythmias during low glucose variability compared to high glucose variability. | 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 | Within 12 months |
Part 2: The relationship between cardiovascular disease at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV | 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 |
Part 2: The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV | The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV | Within 12 months |
Part 2: The relationship between diabetes complication status at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV | The relationship between diabetes complication status (neuropathy, nephropathy, retinopathy) at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV | Within 12 months |
Part 2: Correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias | Correlation between prevalence and total duration of hypoglycaemia and risk of clinically relevant arrhythmias | Within 12 months |
Part 2: Correlation between plasma glucose variation and risk of clinical relevant arrhythmias | Correlation between plasma glucose variation (variation in plasma glucose (Δ mmol/l) within two hours of the event) and risk of clinical relevant arrhythmias | Within 12 months |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
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
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)
University Hospital, Gentofte, CopenhagenPartie responsable de l'étude
Andreas Andersen, Investigateur principal, MD, PhD-student, University Hospital, Gentofte, Copenhagen
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
Gentofte Hospital, Hellerup, 2900, Denmark