Measurement of the Pancreas Function in Patients With More Than One Pancreas After Liver and Small Bowel Transplantation

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621516
• Other study ID #: BCFTX 001
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: November 9, 2015
• Start date: June 2012
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance
• Liver/Small Bowel Transplant

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Universitaire Ziekenhuizen Leuven, Vrije Universiteit Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test	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)	One time	No