The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · May 14, 2024

Keywords

ClinConnect Summary

The RAID-II trial is looking at how adrenaline, a hormone that helps raise blood sugar levels during low blood sugar episodes (called hypoglycemia), affects the immune system. People with type 1 diabetes often experience hypoglycemia because they need to take insulin to manage their blood sugar, which can sometimes drop too low. This study aims to understand how adrenaline activates the immune system during these low blood sugar events, even when there are no infections to fight. By giving participants medications that block the effects of adrenaline, the researchers hope to see how this affects the immune response during hypoglycemia.

To participate in this trial, you need to be between 16 and 75 years old, have a body mass index (BMI) between 18.5 and 35, and be a non-smoker. If you have type 1 diabetes, you should have been on insulin treatment for more than a year. However, certain conditions like a history of heart disease, pregnancy, or specific medications might exclude you from joining. If eligible, participants will experience a controlled drop in blood sugar and receive medications during the trial to help researchers learn more about the connection between adrenaline and the immune response. This study could lead to better understanding and management of hypoglycemia and its effects on health.

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Eligibility criteria

• Inclusion Criteria:
• * Overall inclusion criteria:
• • Ability to provide written informed consent
• • Body-Mass Index: 18,5-35 kg/m2
• • Age ≥16 years, ≤ 75 years
• • Blood pressure: \<140/90 mmHg
• • Non-smoking
• • Electrocardiogram not showing any serious arrythmias (premature ventricular complexes and premature atrial complexes accepted)
• Diabetes group specific criteria:
• • Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
• • Duration of diabetes \> 1 year
• • HbA1c \< 100 mmol/mol,
• Exclusion Criteria:
• • Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, symptomatic peripheral arterial disease)
• • Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
• • Active epilepsy ( with the need for treatment)
• • Allergy for sulphite
• • Active asthma with use of β2-bronchodilators or obstructive lung disease
• • Current treatment with Alpha- or beta-blockers (e.g. doxazosin, propranolol)
• • History of clinical significant Arrhythmias
• • Use of immune-modifying drugs or antibiotics
• • Use of antidepressants ( Including monoamine oxidase inhibitors, tricyclic antidepressants and serotonin-reuptake inhibitors)
• • Use of antipsychotics
• • Use of statins with the inability to stop statins \>2 weeks before the investigational day.
• • Proliferative retinopathy
• • Nephropathy with an estimated glomerular filtration rate (by Chronic Kidney Disease Epidemiology Collaboration equation, CKD-EPI) ˂60ml/min/1.73m2