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:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT05054361
Eligibility Criteria:
Inclusion Criteria:
Recent onset group
* age \> 12 months and \< 15 years
* recently diagnosed type 1 diabetes according ISPAD criteria
At risk subjects:
* age \> 12 months and \< 15 years
* siblings of type 1 diabetic patient
* HLA DR3 and DR4 positive
Control subjects:
* age \> 12 months and \< 15 years
* no HLA associated with high risk type 1 diabetes
* no antibodies against pancreas antigenes
Control subjects for UGI endoscopy:
* age \> 12 months and \< 15 years
* suspicion of coeliac disease or gastritis
Exclusion Criteria:
For all groups:
* no health care insurance
* parents or tutors unable to sign the consent
* personal history of autoimmune disease and/or inflammatory disease except from T1D for RD and CE groups
* use of corticosteroids during the month before inclusion
* pregnant subjects
* medical contraindication of anesthetic topics
For control subjects for UGI endoscopy control and Recent onset-endoscopy group:
* age below 8 years for Recent onset-endoscopy group
* age below 4 for UGI endoscopy control group
* cardiac or respiratory insufficiency, cardiac rhythm disorders, coagulation disease, patients treated with anticoagulant or antiaggregant drug
* history of allergy to anesthetic drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
15 Years
Study:
NCT05054361
Study Brief:
Protocol Section:
NCT05054361