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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT05766657
Eligibility Criteria:
Inclusion Criteria:
1. Eligible for participation will be children diagnosed with obesity (BMI \> 95th percentile) and type 1 diabetes aged 8-18 years
2. Signature of informed consent
Exclusion Criteria:
1. Children with any acute or chronic disease (cancer, infection, other), gastrointestinal disease, cardiovascular disease, chronic kidney disease, parathyroid disease, diseases requiring regular phlebotomies, and other chronic diseases that could affect the results of the present study
2. Taking medications other than insulin, including hypolipidemic and antihypertensive drugs
3. Use of medications that could affect the results of the study, including systemic glucocorticoids and antibiotics (in the three months prior to the study)
4. Recent weight loss or weight gain (\> 3 kg), (in the 3 months preceding the study)
5. Blood transfusion in the last 3 months prior to blood sampling
6. Use of dietary supplements, including multivitamins, fish oil capsules, minerals and trace elements (three months prior to and throughout the study period)
7. Inability (physically or psychologically) to comply with the procedures required by the protocol
8. Children with specific eating disorders, which may hinder the research results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT05766657
Study Brief:
Protocol Section:
NCT05766657