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Role of adrenaline in the inflammatory response in people with diabetes mellitus type 1, and healthy individuals

Role of adrenaline in the inflammatory response in people with diabetes mellitus type 1, and healthy individuals - Adrenaline induced inflammation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53203
Enrollment
30
Registered
2023-09-07
Start date
2023-11-23
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenaline induced inflammation inflammation of the whole body caused by the stress hormone adrenaline

Interventions

Participants will receive a continuous adrenaline infusion at a continuous rate of 0.04 µg/kg/min for 60 minutes. The infusion will start after a 30 minute equilibration period follow insertion of t

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Ability to provide written informed consent Body-Mass Index: 19-30 kg/m2 Age >=16 years,

Exclusion criteria

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 birth control measures 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 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 highe

Design outcomes

Primary

MeasureTime frame
The amount of monocytes following 60 minutes of adrenaline infusion compared to baseline to asses the adrenaline effect on the inflammatory response. .

Secondary

MeasureTime frame
* Leukocyte count at the time points 30 minutes, 60 minutes, +1 day, +3 days and 1 week after start infusion. * Leukocyte phenotype using flow cytometry ( e.g. Granulocytes, NK-cells) * Ex vivo production of pro- and anti-inflammatory cytokines and chemokines after ex vivo stimulation of isolated monocytes, including TNF-a, IL-6, IL-10 and IL-1β. * Distribution of pro- and anti-inflammatory monocyte subsets using FACS (Fluorescence-activated Cell Sorting) * Pro-inflammatory proteins using Olink Proteomics AB inflammation panel with 92 circulating inflammatory proteins (29) ( e.g. EN-rage, FIT3L) * Inflammatory plasma protein using ELISA, ( e.g high sensitive-crp) * Atherogenic parameters using ELISA method including but not limited to, VCAM-1, ICAM-1, E-Selectin, P-selectin, PAI-1, Plasma Endothelin * Plasma levels of hormones ( Cortisol, insulin, glucagon, growth-hormone, adrenaline, noradrenaline) * Glucose variability measured by the blinded continuous glucose monitor including but not limited to, measuring time within range, amount of hypoglycaemic events, amount of hyperglycaemic events. Other study parameters - HbA1c - Creatinine - Vitals ( blood pressure and heart rate) - BMI - Age - Sex - Duration of diabetes ( years) - Hypoglycaemia awareness using the Clarke questionnaire owth-hormone)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)