Transplant, Diabetes
Conditions
Keywords
euglycemic, transplant, pancreas, hyperglycemic, kidney
Brief 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.
Detailed description
Type I diabetes mellitus (DM1) is an autoimmune disease characterized by destruction of the insulin-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 after 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.
Interventions
PROCEDUREOral glucose tolerance test
test done over 2 hours
PROCEDUREIV Glucose Tolerance Test
Done over 4 hours
Sponsors
University of Nebraska
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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: *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate beta cell secretion | 9 months post-transplant or at time of participation for controls | Evaluate beta cell secretion by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours) |
| Evaluate insulin sensitivity/glucose effectiveness | 9 months post-transplant or at time of participation for controls | Evaluate insulin sensitivity/glucose effectiveness by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours) |
Countries
United States
Outcome results
None listed