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The investigators hypothesise that patients with type 1 diabetes have clinically relevant, but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or clinically significant fluctuations in plasma glucose. Furthermore, the investigators hypothesise that following episodes of hypoglycaemia, rebound hyperglycaemia may result in a prolonged period of increased QTc and, thereby, increased susceptibility to serious cardiac arrhythmias.
In this study, changes in cardiac rhythm, haemodynamic regulation, and hormonal response will be evaluated during insulin-induced hypoglycaemia followed by hyperglycaemia and euglycaemia, respectively, on two separate experimental days. Twenty-four patients with type-1 diabetes are included. Patients are randomised 1:1 to start with either the combined hypo- and hyperglycaemic or the hypo- and euglycaemic clamp. After an overnight 10 hour fast, participants are admitted for a 255 minute clamp. An individualised insulin infusion will be initiated targeting a plasma glucose level of 5.0-8.0 mmol/l. When the targeted plasma glucose level is achieved, the hyperinsulinaemic euglycaemic clamp will be initiated at time 0. The insulin infusion will be fixed at an infusion rate 80 mU/m2/min and a 20% glucose infusion will be initiated in order to regulate plasma glucose levels. After 45 min of monitoring at euglycaemic plasma glucose level, plasma glucose will be decreased over a period of 30 minutes, targeting 2.5 mmol/l for a period of 60 min in a hyperinsulinaemic hypoglycaemic clamp. From 135 min to 195 min, plasma glucose levels will be increased to either hyperglycaemic level (20mmol/l) or normoglycaemic (6mmol/L) and will be kept constant for 105 minutes. Echocardiography is performed at baseline, at hypoglycaemic level and at hyper-or normoglycaemic level. Blood samples are taken every 15 minutes throughout the entire clamp, however bedside plasma glucose is analysed every fifth minute. A Holter-ECG is obtained throughout the entire clamp.
Hypoglycemic combined with either normo or hyperglycemic clamp.
Clinical Metabolic Physiology, SDCC
Active, not recruiting
Steno Diabetes Center Copenhagen
Published on BioPortfolio: 2019-05-23T20:21:33-0400
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