Status:
COMPLETED
Role of Adrenaline in in the Inflammatory Response in Diabetes
Lead Sponsor:
Cees Tack
Conditions:
Inflammatory Response
Diabetes Type1
Eligibility:
All Genders
16-75 years
Phase:
NA
Brief Summary
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 c...
Detailed Description
Objective: The aim of the present study is to study the effect of increased adrenaline levels on the inflammatory response (e.g. leukocyte phenotype, cytokines, inflammatory proteins) by administering...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05990933
Start Date
December 3 2023
End Date
September 3 2024
Last Update
November 21 2024
Active Locations (1)
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1
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6525GA