Measurement of the Pancreas Function in Patients With More Than One Pancreas After Liver and Small Bowel Transplantation
Measurement of ß-cell Function and Insulin Sensitivity in Non-diabetic Patients With En-bloc Liver, Pancreas and Small Bowel Transplant Using a Hyperglycemic Clamp
1 other identifier
observational
6
0 countries
N/A
Brief Summary
Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a tendency to develop in the long-term diabetes. Patients who have received extra pancreatic tissue with their liver and small bowel transplantation have not yet developed insulin resistance or diabetes mellitus. We would like to investigate to which level insulin secretory capacity the extra pancreas together with the native pancreas has in these transplant patients using the hyperglycemic clamp. These data will be compared with the data obtained from healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2012
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 11, 2015
November 1, 2015
1.8 years
June 14, 2012
November 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test
1. Sampling before glucose infusion (-30 to 0 minutes) 2. Glucose infusion (0 to 14 minutes) \- increase of glycemia acutely to 180 mg/dL in approx. 14 min. 3. Clamping at glycemia of 180 mg/dL (15 to 150 minutes) * maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion * blood sample for measurement of glycemia, proinsulinemia and C-peptide at 120, 135 and 150 minutes (n= 3x5 ml) for evaluation of second-phase insulin release 4. Intravenous injection of 1 mg glucagon (150 to 170 minutes)
One time
Study Arms (3)
Healthy controls
10 healthy volunteers
Solitary small bowel transplant patients
3
Liver/small bowel transplant patients
3
Eligibility Criteria
Liver/small bowel transplant patients with partial or whole pancreas (n = 3): Solitary small bowel transplant patients (n=3) * Insuline independen (no diabetes mellitus) * Maintenance IS with Tacrolimus/Azathioprine
You may qualify if:
- Liver/small bowel transplant patients with partial or whole pancreas
- Solitary small bowel transplant patients
- Insulin independent (no diabetes mellitus)
- Maintenance IS with Tacrolimus/Azathioprine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
- Universitaire Ziekenhuizen KU Leuvencollaborator
- Vrije Universiteit Brusselcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr.
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 18, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2014
Study Completion
November 1, 2015
Last Updated
November 11, 2015
Record last verified: 2015-11