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

This study has been completed.
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Vrije Universiteit Brussel
Information provided by (Responsible Party):
prof. Pieter Gillard, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01621516
First received: June 14, 2012
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
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.

Condition
Diabetes
Insulin Resistance
Liver/Small Bowel Transplant

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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 ]
    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)


Enrollment: 6
Study Start Date: June 2012
Study Completion Date: November 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy controls
10 healthy volunteers
Solitary small bowel transplant patients
3
Liver/small bowel transplant patients
3

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: prof. Pieter Gillard, prof. dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01621516     History of Changes
Other Study ID Numbers: BCFTX 001 
Study First Received: June 14, 2012
Last Updated: November 9, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
Beta-cell function
Liver/small bowel transplant
Donor pancreas
Diabetes
Long-term immunesuppression

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 25, 2016