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Hypoglycemia and Cardiac Arrhythmias in Type 1 Diabetes

2019-05-23 20:21:33 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Diabetes type1

Intervention

Hypoglycemic combined with either normo or hyperglycemic clamp.

Location

Clinical Metabolic Physiology, SDCC
Copenhagen
Denmark
2900

Status

Active, not recruiting

Source

Steno Diabetes Center Copenhagen

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-05-23T20:21:33-0400

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