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

University Hospital, Gentofte, Copenhagen

Status

Completed

Conditions

Arrhythmia, Cardiac

Diabetes Mellitus, Type 2

Treatments

Other: Combined hyper- and hypoglycaemic clamp

Device: Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)

Device: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA)

Study type

Observational

Funder types

Other

Identifiers

NCT03150030

H-16046212

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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)