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临床试验/NCT01621516
NCT01621516已完成不适用

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

KU Leuven0 个研究点目标入组 6 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
6
主要终点
Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Change in the stimulated serum C-peptide leveS (mean area under the curve [AUC] after hypercemic clamp test

时间窗: One time

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)

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. Pieter Gillard

prof. dr.

KU Leuven

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