Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Omaha, Nebraska 68198


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

114-00FB


NCT ID:

NCT00571818


Secondary ID:


Study Acronym:


Brief Title:

The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients


Official Title:

The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Nebraska


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model: Si


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

31


Enrollment Type:

Actual


Overall Contact Information

Official Name:James T. Lane, MD
Principal Investigator
University of Nebraska

Study Dates

Start Date:November 2000
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:March 2008
Primary Completion Type:Actual
Verification Date:May 2015
Last Changed Date:May 26, 2015
First Received Date:December 11, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Oral glucose tolerance test
Description:test done over 2 hours
Arm Name:EP
Intervention Type:Procedure
Name:IV Glucose Tolerance Test
Description:Done over 4 hours
Arm Name:EP

Study Arms

Study Arm Type:Active Comparator
Arm Name:EP
Study Arm Type:Active Comparator
Arm Name:HP
Study Arm Type:Active Comparator
Arm Name:EK
Study Arm Type:Active Comparator
Arm Name:HC

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Nebraska

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.