DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients

Information source: University of Nebraska
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transplant; Diabetes

Intervention: Oral glucose tolerance test (Procedure); IV Glucose Tolerance Test (Procedure)

Phase: N/A

Status: Completed

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
James T. Lane, MD, Principal Investigator, Affiliation: University of Nebraska

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.

Clinical Details

Official title: The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Evaluate beta cell secretion, insulin sensitivity, and glucose effectiveness, in euglycemic & hyperglycemic pancreas transplant pts,& euglycemic kidney transplant pts at least 9 months post-transplant as well as normal controls.

Detailed description: 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.

Eligibility

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States
Additional Information

Starting date: November 2000
Last updated: May 26, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017