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Sponsored by: |
University of Nebraska |
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Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00571818 |
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.
Condition | Intervention |
---|---|
Transplant Diabetes |
Procedure: Oral glucose tolerance test Procedure: IV Glucose Tolerance Test |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients |
Estimated Enrollment: | 40 |
Study Start Date: | November 2000 |
Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
---|---|
EP: Active Comparator |
Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours
|
HP: Active Comparator |
Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours
|
EK: Active Comparator |
Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours
|
HC: Active Comparator |
Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours
|
Type I diabetes mellitus (DM1) is an autoimmune disease characterized by destruction of the in sulin-secreting beta cells. Insulin replacement has been the cornerstone of therapy for patients with DM1. However, pancreas transplantation, utilizing the whole pancreas as a means to replace the destroyed beta cells, has become a therapeutic alternative. The goal of pancreas transplantation is the establishment of long-term euglycemia, thereby preventing or allowing for the repair of end-organ complications.
Maintenance of the pancreas allograft over many years remains the goal in following pancreas transplant recipients over time. The onset of hyperglycemia less than one year after transplant is usually due to issues of surgical technique or acute rejection. HOwever, the onset of hyperglycemia fter one year of pancreas transplant is more problematic because the underlying causes are less clear and have been less well characterized. Currently, there is no protocol for definitively identifying the causes of hyperglycemia in pancreas transplant recipients over one year. This project will systematically characterize beta cell function and peripheral tissue response to insulin in patients who have received an earlier successful pancreas transplant who have developed hyperglycemia.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Hyperglycemic pancreas transplant recipients:
Euglycemic pancreas transplant recipients:
Euglycemic Kidney Transplant Recipients:
Euglycemic Healthy Control Subjects:
Exclusion Criteria:
Hyperglycemic pancreas transplant recipients:
Euglycemic pancreas transplant recipients:
Euglycemic Kidney Transplant Recipients:
Euglycemic Healthy Control Subjects:
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | James T. Lane, MD | University of Nebraska |
Responsible Party: | Univerisity of Nebraska Medical Center ( James Lane, MD ) |
Study ID Numbers: | 114-00FB |
Study First Received: | December 11, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00571818 |
Health Authority: | United States: Institutional Review Board |
euglycemic transplant pancreas hyperglycemic kidney |
Diabetes Mellitus Pancrelipase |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |