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The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00571818
First received: December 11, 2007
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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. [ Time Frame: two visits ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2000
Study Completion Date: June 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EP Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours
Active Comparator: HP Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours
Active Comparator: EK Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours
Active Comparator: HC Procedure: Oral glucose tolerance test
test done over 2 hours
Procedure: IV Glucose Tolerance Test
Done over 4 hours

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571818

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: James T. Lane, MD University of Nebraska
  More Information

No publications provided

Responsible Party: James Lane, MD, Univerisity of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00571818     History of Changes
Other Study ID Numbers: 114-00FB
Study First Received: December 11, 2007
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
euglycemic
transplant
pancreas
hyperglycemic
kidney

ClinicalTrials.gov processed this record on November 27, 2014