Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05990933
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT05990933
Study Brief:
Protocol Section:
NCT05990933