NCT05990933Completed
Role of Adrenaline in in the Inflammatory Response in Diabetes
Role of Adrenaline in the Inflammatory Response in People with Diabetes Mellitus Type 1, and Healthy Individuals
Source: ClinicalTrials.gov · Last updated 21 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 2 Aug 2023
- Start date
- 3 Dec 2023
- Primary completion date
- 3 Sept 2024
- Lead sponsor
- Cees Tack
- Diseases
- Type 1 diabetes
- NCT number
- NCT05990933
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 3 Dec 2023 to the primary completion date, 3 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with Alpha or beta blockers ( doxazosin, propranolol)
- 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.
- Previous vaccination in the past 2 weeks
Other illness
- Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease)
- Epilepsy
- History of panic disorders
- History of Arrhythmias
- Any infection with systemic symptoms in past 2 weeks
Other
- Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
- Proliferative retinopathy
- Nephropathy with an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2
Criteria the registry did not label
- 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,
Age in the registry: 16 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud UMC Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
Related publications
- Adrenaline is a prominent driver of inflammatory responses following hypoglycaemia.Diabetologia · 2026 · PMID 41611977
This page is information, not medical advice. Discuss any trial with your doctor.