The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients
NCT ID: NCT00571818
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
31 participants
INTERVENTIONAL
2000-11-01
2010-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardiovascular Risk Factors After Single Pancreas Transplantation
NCT02066350
The Role of Pulsatile Insulin Secretion (A Study Investigating the Effects of Partial Pacreatectomy on Glucose Metabolism)
NCT00841867
Arginine-stimulated Indication of Early Outcome After Islet Transplantation
NCT05540197
Investigating Predictive Factors of Diabetes Occurence After Duodenalpancreatectomy
NCT02175459
Human Versus Analogue Insulin in Patients After Pancreatectomy.
NCT04690309
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Euglycemic pancreas transplant recipients
Participants receiving a pancreas transplant who have blood glucose level is within the normal range
Oral glucose tolerance test
test done over 2 hours
IV Glucose Tolerance Test
Done over 4 hours
Hyperglycemic pancreas transplant recipients
Participants receiving a pancreas transplant who have high blood glucose (blood sugar)
Oral glucose tolerance test
test done over 2 hours
IV Glucose Tolerance Test
Done over 4 hours
Euglycemic Kidney Transplant Recipients
Participants receiving a kidney transplant who have blood glucose level is within the normal range
Oral glucose tolerance test
test done over 2 hours
IV Glucose Tolerance Test
Done over 4 hours
Euglycemic Healthy Control Participants
Participants who do not receive either a pancreas or kidney transplant who have blood glucose level is within the normal range
Oral glucose tolerance test
test done over 2 hours
IV Glucose Tolerance Test
Done over 4 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral glucose tolerance test
test done over 2 hours
IV Glucose Tolerance Test
Done over 4 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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:
* no diagnosis of type 2 diabetes.
* Euglycemic Kidney Transplant Recipients:
* 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.
19 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nebraska
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James T Lane, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0114-00-FB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.