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Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes (HYPO-HEART)

30 oktober 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Werkelijk)

42

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Hellerup, Denemarken, 2900
        • Gentofte Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patiens with insulin-treated type 2 diabetes with complications and healthy controls

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients with type 2 diabetes
Insulin-treated type 2 diabetes with diabetic complications
Ander: 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 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.
Apparaat: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA)
Implantation of a loop-recorder
Apparaat: Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)
Monitoring with a continuous glucose monitor
Gezonde controles
Gezonde controlepersonen
Ander: 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 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: Clinically relevant arrhythmias
Tijdsspanne: 0-240 min during the combined hyper- and hypoglycaemic clamp
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
Tijdsspanne: Within 12 months
Prevalence of clinically relevant arrhythmias as defined above
Within 12 months
Part 2: Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia
Tijdsspanne: Within 12 months
Clinically relevant arrhythmias during hypoglycaemia compared to euglycaemia
Within 12 months
Part 2: Difference in MAGE
Tijdsspanne: Within 12 months
Difference in mean amplitude of glycaemic excursions (MAGE) two hours preceding an arrhythmic event versus MAGE during non-event
Within 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: Differences in mean corrected QT interval (QTc)
Tijdsspanne: 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
0-240 min during the combined hyper- and hypoglycaemic clamp
Part 1: Difference in counter regulatory hormonal response
Tijdsspanne: 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
0-240 min during the combined hyper- and hypoglycaemic clamp
Part 1: Differences in haemodynamic regulation
Tijdsspanne: 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
Part 2: Clinical relevant arrhythmias during low glucose variability compared to high glucose variability.
Tijdsspanne: Within 12 months
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
Tijdsspanne: 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
Part 2: The relationship between pharmacological treatment at baseline and clinically relevant arrhythmias in relation to hypoglycaemia and HGV
Tijdsspanne: Within 12 months
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
Tijdsspanne: Within 12 months
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
Tijdsspanne: Within 12 months
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
Tijdsspanne: Within 12 months
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Gentofte, Copenhagen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2017

Primaire voltooiing (Werkelijk)

6 januari 2020

Studie voltooiing (Werkelijk)

6 januari 2020

Studieregistratiedata

Eerst ingediend

25 april 2017

Eerst ingediend dat voldeed aan de QC-criteria

10 mei 2017

Eerst geplaatst (Werkelijk)

11 mei 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 november 2020

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H-16046212

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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