Diabetes Clinical Trial
Official title:
The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients
Verified date | October 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | June 1, 2010 |
Est. primary completion date | March 1, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | 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 = 1.5 mg/dl - BMI > 30 kg/m2. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate beta cell secretion | Evaluate beta cell secretion by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours) | 9 months post-transplant or at time of participation for controls | |
Primary | Evaluate insulin sensitivity/glucose effectiveness | Evaluate insulin sensitivity/glucose effectiveness by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours) | 9 months post-transplant or at time of participation for controls |
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