Clinical trial NCT01621516: Measurement of the Pancreas Function in Patients With More Than One Pancreas After Liver and Small Bowel Transplantation
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Insulin Resistance
Liver/Small Bowel Transplant
Keywords: Beta-cell function
Liver/small bowel transplant
Donor pancreas
Diabetes
Long-term immunesuppression
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Vrije Universiteit Brussel
First posted: 2012-06-18
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Detailed description: The glycemic control in type 1 diabetic recipients of islet cell grafts is correlated with the ß-cell mass. In the standard technique for liver/small bowel transplant procedure previously described by Grant et al, the pancreas was removed. This surgical method was modified by Sudan et al and the donor pancreas was transplanted intact in these non-diabetic patients. Under chronic immunosuppressive and corticosteroid therapy, these patients with extra ß-cell mass have not developed insulin resistance or diabetes mellitus. To which level insulin secretory capacity the extra pancreas allograft together with the native pancreas has in these transplant patients are not yet known.

Among the measures of pancreatic ß-cell-secretory capacity, the first-phase and steady state insulin secretion from the hyperglycemic clamp studies are believed to give the most robust estimates. Moreover, the hyperglycemic clamp and the euglycemic clamp yield comparable estimates of insulin sensitivity and, so that under appropriate conditions, the hyperglycemic clamp technique may be used to assess both insulin sensitivity and insulin secretion in the same individual in a single experiment.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test
timeFrame: One time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: