Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes
NCT ID: NCT03150030
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2017-02-01
2020-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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 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.
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 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.
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
Yes
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Andreas Andersen
MD, PhD-student
Locations
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Gentofte Hospital
Hellerup, , Denmark
Countries
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References
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Andersen A, Bagger JI, Sorensen SK, Baldassarre MPA, Pedersen-Bjergaard U, Forman JL, Gislason G, Lindhardt TB, Knop FK, Vilsboll T. Associations of hypoglycemia, glycemic variability and risk of cardiac arrhythmias in insulin-treated patients with type 2 diabetes: a prospective, observational study. Cardiovasc Diabetol. 2021 Dec 24;20(1):241. doi: 10.1186/s12933-021-01425-0.
Other Identifiers
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H-16046212
Identifier Type: -
Identifier Source: org_study_id