Role of Adrenaline in the Inflammatory Response in People With Diabetes Mellitus Type 1, and Healthy Individuals

114664

The primary aim of the present study is to study the effect of adrenaline administration on inflammatory parameters (e.g. leukocyte phenotype, cytokines, inflammatory proteins). Secondary objectives consist of the effect of adrenaline on atherogenic parameters. * All participants will receive intravenous infusion of adrenaline for an hour * We will draw blood at 7 time points, not including screening * Participants will be asked to return for a total of 4 times Researchers will compare 2 groups, healthy individuals versus people with diabetes type 1 to see if the inflammatory reaction to adrenaline differs between these two groups.

2023-09-01

2024-10-01

2024-10-01

Not yet recruiting

30

Overall inclusion criteria: * Ability to provide written informed consent * Body-Mass Index: 19-30kg/m2 * Age ≥16 years, ≤ 75 years * Blood pressure: \<140/90 mmHg * Non-smoking * Electrocardiogram not showing any serious arrythmia's (PVC's and PAC's 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, heart failure, symptomatic peripheral arterial disease) * Pregnancy or breastfeeding or unwillingness to undertake measures for birth control * Epilepsy, * Current treatment with Alpha or beta blockers ( doxazosin, propranolol) * History of panic disorders * History of Arrhythmias * Use of immune-modifying drugs or antibiotics * Use of tricyclic antidepressants or MAO inhibitors * Use of statins (e.g. stop statins \>2 weeks before performing blood sampling. * Any infection with systemic symptoms in past 2 weeks * Previous vaccination in the past 2 weeks * Proliferative retinopathy * Nephropathy with an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2 * Overt impaired hypoglycaemic awareness assed by the Clarke Questionnaire 4 or higher

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour. We will draw blood at baseline, 30 minutes, 60 minutes, 180 minutes, 24 hours 72 and a week after start of infusion. These samples will be used for phenotyping of the innate immune system and measuring inflammatory and atherogenic parameters. Throughout the infusion vital parameters will be monitored.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-08-14