NCT03150030

Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diabetes Mellitus, Type 2
• Arrhythmia, Cardiac

Interventions

Type	Name	Description
OTHER	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.
DEVICE	Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA)	Implantation of a loop-recorder
DEVICE	Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)	Monitoring with a continuous glucose monitor

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-01-06
• Completion: 2020-01-06
• First posted: 2017-05-11
• Last updated: 2020-11-02

Locations

1 site across 1 country: Denmark