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 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT05054712
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged ≥ 18 years.
* Diagnosed with T1D of at least 6 months of evolution.
* Patients who give their informed consent in writing.
Exclusion Criteria:
* Active alcoholism\> 30 g / day in men and\> 20 g / day in women.
* Known non-metabolic liver disease: alcoholic hepatitis, viral hepatitis from HBV infection and / or HCV, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, autoimmune hepatitis, hepatic granulomatous (tuberculosis, mycobacteria, histoplasmosis), hepatic lymphoma, primary neoplasia liver, liver metastasis.
* Active treatment with hepatotoxic drugs: amiodarone, isoniazid, rifampicin, sulfa drugs, tetracyclines, amoxycline / clavulanate, ketoconazole, methotrexate, valproic acid, trazodone, tamoxifen, methyldopa, reverse transcriptase inhibitors, chemotherapy, immunotherapy.
* Pregnant women.
* Acute decompensation of T1D (ketoacidosis) in the 3 months prior to inclusion. The inclusion after this period.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05054712
Study Brief:
Protocol Section:
NCT05054712