Measurement of the Pancreas Function in Patients With More Than One Pancreas After Liver and Small Bowel Transplantation
Liver/Small Bowel Transplant
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|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|
- Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test [ Time Frame: One time ] [ Designated as safety issue: No ]
- Sampling before glucose infusion (-30 to 0 minutes)
Glucose infusion (0 to 14 minutes)
- increase of glycemia acutely to 180 mg/dL in approx. 14 min.
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
- Intravenous injection of 1 mg glucagon (150 to 170 minutes)
|Study Start Date:||June 2012|
|Study Completion Date:||November 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
10 healthy volunteers
Solitary small bowel transplant patients
Liver/small bowel transplant patients
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.
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