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Clinical Trial Details

Trial ID: L6787
Source ID: NCT05990933
Associated Drug: Adrenaline
Title: Role of Adrenaline in in the Inflammatory Response in Diabetes
Acronym: RAID
Status: COMPLETED
Study Results: NO
Results:
Conditions: Inflammatory Response|Diabetes Type1|Hypoglycemia
Interventions: DRUG: Adrenaline
Outcome Measures: Primary: Monocyte count, The amount of monocytes following 60 minutes of adrenaline infusion compared to baseline to asses the adrenaline effect on the inflammatory response., Change from baseline compared to after 1 hour | Secondary: Leukocyte count, Measurement of the amount of leukocytes, Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion|Leukocyte phenotype, Measuring several phenotypes by using a pre-defined panel of interest with flow-cytometry ( e.g. NK-cells, granulocytes), Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion|Pro-inflammatory proteins, Pro-inflammatory proteins using Olink Proteomics AB inflammation panel with 92 circulating inflammatory proteins ( e.g. EN-rage, FIT3L), Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion|Inflammation plasma parameters, Inflammatory plasma protein using ELISA, ( e.g high sensitive-crp), Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion|Atherogenic parameters, Atherogenic parameters using ELISA method including but not limited to, VCAM-1, ICAM-1, E-Selectin, P-selectin, PAI-1, Plasma Endothelin, Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion|Insulin, Plasma levels of insulin, Change from baseline at, 60 and 180 minutes|Adrenaline, Plasma levels of adrenaline, Change from baseline at 30, 60 and 180 minutes|Noradrenaline, Plasma levels of noradrenaline, Change from baseline at 30, 60 and 180 minutes|Glucose variability, 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., 2 weeks|Ex vivo cytokines, Ex vivo production of pro- and anti-inflammatory cytokines and chemokines after ex vivo stimulation of isolated monocytes, including TNF-α, IL-6, IL-10 and IL-1β., Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion|Distribution of monocyte subset, Distribution of pro- and anti-inflammatory monocyte subsets using FACS (Fluorescence-activated Cell Sorting), Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion
Sponsor/Collaborators: Sponsor: Cees Tack
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-12-03
Completion Date: 2024-09-03
Results First Posted:
Last Update Posted: 2024-11-21
Locations: Radboud UMC, Nijmegen, Gelderland, 6525GA, Netherlands
URL: https://clinicaltrials.gov/show/NCT05990933