TransplantNCT00571818
The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients
A study testing Oral glucose tolerance test and IV Glucose Tolerance Test in people with Transplant and Diabetes, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplant, Diabetes
- What is being tested?
- Oral glucose tolerance test and IV Glucose Tolerance Test
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2000to 1 Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the detailed description
Type I diabetes mellitus (DM1) is an autoimmune disease characterized by destruction of the insulin-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 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
- Transplant, Diabetes
- Being tested
- Oral glucose tolerance test, IV Glucose Tolerance Test
- Keywords
- euglycemic, transplant, pancreas, hyperglycemic, kidney
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testProcedure or surgery
test done over 2 hours
IV Glucose Tolerance TestProcedure or surgery
Done over 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Euglycemic pancreas transplant recipients | Active comparator | Participants receiving a pancreas transplant who have blood glucose level is within the normal range Receives: Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test |
| Hyperglycemic pancreas transplant recipients | Active comparator | Participants receiving a pancreas transplant who have high blood glucose (blood sugar) Receives: Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test |
| Euglycemic Kidney Transplant Recipients | Active comparator | Participants receiving a kidney transplant who have blood glucose level is within the normal range Receives: Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test |
| Euglycemic Healthy Control Participants | Active comparator | Participants who do not receive either a pancreas or kidney transplant who have blood glucose level is within the normal range Receives: Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 9 months post-transplant or at time of participation for controls
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)
Measured: 9 months post-transplant or at time of participation for controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study start1 Nov 2000
- Primary completion1 Mar 2008
- Study completion1 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James T Lane, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571818
- Sponsor's protocol ID
- 0114-00-FB
- Status last verified
- Oct 2023
- First submitted
- 11 Dec 2007
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients
- ClinicalTrials.gov ID
- NCT00571818
- Acronym / sponsor ID
- 0114-00-FB
- Conditions
- Transplant, Diabetes
- Keywords
- euglycemic, transplant, pancreas, hyperglycemic, kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Nov 2000 (actual)
- Primary completion
- 1 Mar 2008 (actual)
- Study completion
- 1 Jun 2010 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type I diabetes mellitus (DM1) is an autoimmune disease characterized by destruction of the insulin-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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Euglycemic pancreas transplant recipients | Active comparator | Procedure: Oral glucose tolerance test, Procedure: IV Glucose Tolerance TestParticipants receiving a pancreas transplant who have blood glucose level is within the normal range |
| Hyperglycemic pancreas transplant recipients | Active comparator | Procedure: Oral glucose tolerance test, Procedure: IV Glucose Tolerance TestParticipants receiving a pancreas transplant who have high blood glucose (blood sugar) |
| Euglycemic Kidney Transplant Recipients | Active comparator | Procedure: Oral glucose tolerance test, Procedure: IV Glucose Tolerance TestParticipants receiving a kidney transplant who have blood glucose level is within the normal range |
| Euglycemic Healthy Control Participants | Active comparator | Procedure: Oral glucose tolerance test, Procedure: IV Glucose Tolerance TestParticipants who do not receive either a pancreas or kidney transplant who have blood glucose level is within the normal range |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Hyperglycemic pancreas transplant recipients:
- Euglycemic pancreas transplant recipients:
- Euglycemic Kidney Transplant Recipients:
- Euglycemic Healthy Control Subjects:
Key exclusion criteria (18 listed)
- Hyperglycemic pancreas transplant recipients:
- Euglycemic pancreas transplant recipients:
- Euglycemic Kidney Transplant Recipients:
- Euglycemic Healthy Control Subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance testtest done over 2 hours | Procedure or surgery | Euglycemic Healthy Control Participants, Euglycemic Kidney Transplant Recipients, Euglycemic pancreas transplant recipients, Hyperglycemic pancreas transplant recipients |
| IV Glucose Tolerance TestDone over 4 hours | Procedure or surgery | Euglycemic Healthy Control Participants, Euglycemic Kidney Transplant Recipients, Euglycemic pancreas transplant recipients, Hyperglycemic pancreas transplant recipients |
Primary outcome
Evaluate beta cell secretion
Time frame: 9 months post-transplant or at time of participation for controls
Evaluate beta cell secretion by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours)
Evaluate insulin sensitivity/glucose effectiveness
Time frame: 9 months post-transplant or at time of participation for controls
Evaluate insulin sensitivity/glucose effectiveness by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James T Lane, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose tolerance test and IV Glucose Tolerance Test in people with Transplant and Diabetes, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate beta cell secretion (time frame: 9 months post-transplant or at time of participation for controls). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.