Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246844
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-10-29
Brief Title:
Assessment of Insulin Production From Native Pancreas in Patients With Pancreas Transplants
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Assessing Arginine-Stimulated Native Pancreas Insulin Production Via Selective Venous Sampling in Patients With Long-Functioning Pancreas Allografts
Status:
COMPLETED
Status Verified Date:
2007-08-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine whether insulin-producing cells in the pancreas beta cells can recover in patients with type 1 diabetes who have had a pancreas transplant In type 1 diabetes the bodys immune system destroys the beta cells Patients are treated with insulin shots or a pancreas transplant to control their blood sugar Some experiments suggest that the pancreas may have the capacity to recover some of its insulin-producing capacity but that ability is negated by factors such as the continuing immune attack and erratic blood sugar levels in patients
Patients who have had a pancreas transplant may be in a unique situation to allow their own pancreas to regrow beta cells for two reasons 1 the medicines they take to prevent rejection of the transplanted pancreas weaken their immune system and 2 they have near-normal blood sugar levels because of their functioning transplanted pancreas This study will test this hypothesis by sampling blood from patients hepatic vein which drains the liver and native pancreas and from their iliac vein which drains the transplanted pancreas This will determine whether insulin is coming from the transplanted pancreas iliac vein or the liver and native pancreas hepatic vein
Patients 18 years of age and older who have had stable pancreatic transplant function for more than 5 years may be eligible for this study Candidates are screened with a medical history and physical examination
Participants are admitted to the hospital for 2 days for a full medical examination blood tests and procedures to determine insulin production The procedures will include the placement of catheters in the neck and groin for blood sampling Participants will be closely monitored after the procedures and discharged home if there are no complications
Patients who have had a pancreas transplant may be in a unique situation to allow their own pancreas to regrow beta cells for two reasons 1 the medicines they take to prevent rejection of the transplanted pancreas weaken their immune system and 2 they have near-normal blood sugar levels because of their functioning transplanted pancreas This study will test this hypothesis by sampling blood from patients hepatic vein which drains the liver and native pancreas and from their iliac vein which drains the transplanted pancreas This will determine whether insulin is coming from the transplanted pancreas iliac vein or the liver and native pancreas hepatic vein
Patients 18 years of age and older who have had stable pancreatic transplant function for more than 5 years may be eligible for this study Candidates are screened with a medical history and physical examination
Participants are admitted to the hospital for 2 days for a full medical examination blood tests and procedures to determine insulin production The procedures will include the placement of catheters in the neck and groin for blood sampling Participants will be closely monitored after the procedures and discharged home if there are no complications
Detailed Description:
Type 1 diabetes mellitus T1DM is thought to result from an autoimmune destruction of insulin producing beta-cells found within the pancreatic islets of Langerhans In addition to the autoimmune process however many studies have shown that hyperglycemia is also toxic to islets Interventional studies have shown for instance that either tight glycemia control or immunosuppression can preserve C-peptide production We hypothesize that patients who are immunosuppressed and euglycemic will display evidence that their native pancreas has recovered beta-cell function We have asked whether pancreas transplant recipients due to the immunosuppression required to prevent allograft loss and the improved glycemia control resulting from the transplanted pancreas might display some recovery of their native pancreatic islet function Our preliminary data suggest that patients without C-peptide production prior to receiving an islet transplant appear to recover some endogenous pancreatic insulin secretion after islet transplantation We will study whole pancreas transplant recipients specifically those with grafts functioning for at least 5 years We will test for native pancreas insulin production by infusing arginine into a peripheral vein then selectivelysimultaneously sampling blood for C-peptide levels from the hepatic veins and the vein draining the pancreatic allograft Unlike our previous study of islet transplant recipients a study that required portal vein cannulation this study will require only hepatic and iliac vein cannulations both much easier to accomplish and associated with much less risk to the patient Samples obtained from these sites will be tested for C-peptide levels In addition if we find evidence of native pancreas insulin production we will look at a variety of clinical variables to see if any correlate with recovery of function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-DK-0019 | None | None | None |