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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT00466518
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes Mellitus
* Most recent HbA1C 6.5-10%
* 1 year post kidney transplant
Exclusion Criteria:
* Patients treated primarily with insulin for their diabetes
* Kidney allograft not functional at entry or estimated creatinine clearance of \<30 ml/min
* Clinical course complicated by persistent nausea
* severe gastroparesis
* Severe recurrent hypoglycemia (\>1 hypoglycemic episode requiring the help of another person per week).
* Patients on dialysis therapy
* Unstable renal function in the preceding 3 months
* Serum transaminases \>2 times normal at study entry
* Smokers
* Pregnant or planning to become pregnant
* Lactating
* Recipients of multi-organ transplants
* Unstable medical conditions which result in multiple hospitalizations or a severely restricted lifestyle
* Hemoglobin \<10.0g/dl
* Use of digoxin
* Patients receiving their primary care outside of UNMC
* Inability to come to follow-up visits as a part of the protocol
* Patients not taking tacrolimus and sarolimus as part of their immunosuppressive therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00466518
Study Brief:
Protocol Section:
NCT00466518