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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT06348706
Eligibility Criteria:
Inclusion Criteria:
* Adolescents diagnosed with type 1 diabetes according to ISPAD guidelines .
* Patients aged 12-18 years with NASH.
* Patients on regular visit to clinic.
* Patients on regular insulin therapy.
Exclusion Criteria:
* Patients with renal impairment due to cause other than diabetes.
* Patients with hypertension.
* Hyper- or hypo-thyroidism.
* Hepatitis virus infection (B or C) or any evidence of infection.
* History of liver disease other than NASH such as cholestasis and Wilson disease.
* Patients with autoimmune hepatitis.
* Recurrent diabetic ketoacidosis (more than 2 episodes in the previous 12 months)
* Patients were already on anti-hypertensive drugs or any antioxidant therapy such as vitamin supplements.
* Taking any vitamins or food supplements one month before study.
* Participation in a previous investigational drug study within 3 months preceding screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT06348706
Study Brief:
Protocol Section:
NCT06348706