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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT05042505
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of diabetes (pre-transplantation type 2 diabetes or new onset diabetes after transplantation)
2. Subjects taking insulin and/or metformin and/or sulfonylurea.
3. Body mass index (BMI) \>=18.5 kg/m2
Exclusion Criteria:
1. Type 1 diabetes
2. Estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2, calculated by the Chronic Kidney Disease - Epidemiology (CKD-EPI) equation
3. Liver aminotransferases \>3 times the upper limit of the reference range (upper normal limit AST or ALT \>=40 units/L)
4. History of recurrent urinary tract infection
5. History or current acute or chronic pancreatitis
6. Pregnancy
7. Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05042505
Study Brief:
Protocol Section:
NCT05042505