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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00980356
Eligibility Criteria:
Inclusion Criteria:
• Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose): glucose ≥ 200mg/dl
* renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of triple therapy with tacrolimus or cyclosporine A, mycophenolate mofetil or azathioprine, and prednisone.
* stable graft function for more than 6 months post transplant.
* informed consent of the patient
Exclusion Criteria:
* patients with prior history of type 1 or type 2 diabetes
* body mass index (BMI) \> 40
* pregnancy
* severe renal impairment (GFR \< 30 mL/min./1.73 m2)
* severe liver impairment
* severe blood glucose elevation with the need for therapy with insulin or HbA1c \>8.5%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00980356
Study Brief:
Protocol Section:
NCT00980356