- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03150030
Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes (HYPO-HEART)
30 oktober 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
42
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Hellerup, Danmark, 2900
- Gentofte Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patiens with insulin-treated type 2 diabetes with complications and healthy controls
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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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Friska kontroller
Friska kontrollämnen
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Part 1: Clinically relevant arrhythmias
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Part 1: Differences in mean corrected QT interval (QTc)
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2017
Primärt slutförande (Faktisk)
6 januari 2020
Avslutad studie (Faktisk)
6 januari 2020
Studieregistreringsdatum
Först inskickad
25 april 2017
Först inskickad som uppfyllde QC-kriterierna
10 maj 2017
Första postat (Faktisk)
11 maj 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 november 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-16046212
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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