The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients (NCT00571818) | Clinical Trial Compass
CompletedNot Applicable
The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients
United States31 participantsStarted 2000-11-01
Plain-language summary
The purpose of this study is to understand how the pancreas functions after transplantation and particularly why high blood sugar levels develop. It will also analyze the effect of the medicines used to prevent rejection on blood sugar levels.
The hypothesis to be tested is that hyperglycemia more than six months after successful pancreas transplant results from a defect in insulin secretion, insulin resistance, or both.
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hyperglycemic pancreas transplant recipients:
* ages 19-65
* received a pancreas transplant ≥ 9 months previously
* fasting glucose levels ≥ 126 mg/dl
* hemoglobin A1C \> 1% above normal
* Euglycemic pancreas transplant recipients:
* ages 19-65
* received a pancreas transplant ≥ 9 months previously
* fasting glucose levels are \< 126 mg/dl
* normal HbA1C without taking any medications for the treatment of high blood sugars.
* Euglycemic Kidney Transplant Recipients:
* ages 19-65
* no prior diagnosis of diabetes
* received a kidney transplant ≥ 9 months previously
* showing continued function
* Euglycemic Healthy Control Subjects:
* ages 19-65
* no diabetes or renal disease
Exclusion Criteria:
* Hyperglycemic pancreas transplant recipients:
* chronic illnesses that would decrease insulin sensitivity (
* terminal illness
* BMI \> 30 kg/m2
* serum creatinine \> 2 mg/dl
* hemoglobin \< 10 g/dl
* an episode of acute rejection with the preceding 3 months of entry.
* Euglycemic pancreas transplant recipients:
* Exclusion criteria are the same as with hyperglycemic transplant patients.
* no diagnosis of type 2 diabetes.
* Euglycemic Kidney Transplant Recipients:
* Exclusion criteria are the same as for euglycemic pancreas transplant recipients above.
* Euglycemic Healthy Control Subjects:
* chronic illnesses
* medications known to affect glucose metabolism
* a history of smoking
* serum creatinine …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate beta cell secretion
Timeframe: 9 months post-transplant or at time of participation for controls