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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT06422494
Eligibility Criteria:
Inclusion Criteria:
* Overall inclusion criteria:
* Ability to provide written informed consent
* Body-Mass Index: 18,5-35 kg/m2
* Age ≥16 years, ≤ 75 years
* Blood pressure: \<140/90 mmHg
* Non-smoking
* Electrocardiogram not showing any serious arrythmias (premature ventricular complexes and premature atrial complexes 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, symptomatic peripheral arterial disease)
* Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
* Active epilepsy ( with the need for treatment)
* Allergy for sulphite
* Active asthma with use of β2-bronchodilators or obstructive lung disease
* Current treatment with Alpha- or beta-blockers (e.g. doxazosin, propranolol)
* History of clinical significant Arrhythmias
* Use of immune-modifying drugs or antibiotics
* Use of antidepressants ( Including monoamine oxidase inhibitors, tricyclic antidepressants and serotonin-reuptake inhibitors)
* Use of antipsychotics
* Use of statins with the inability to stop statins \>2 weeks before the investigational day.
* Proliferative retinopathy
* Nephropathy with an estimated glomerular filtration rate (by Chronic Kidney Disease Epidemiology Collaboration equation, CKD-EPI) ˂60ml/min/1.73m2
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT06422494
Study Brief:
Protocol Section:
NCT06422494