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NCT00618761 Clinical Trial

Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls

Kidney Transplantation Clinical Trial

Official title:
Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Non-Diabetic Kidney Recipients, Insulin Independent Recipients of Beta-cell Grafts and Healthy Controls.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00618761
Other study ID # clamp01
Secondary ID JDRF 4/2005/1327
Status Recruiting
Phase N/A
First received February 6, 2008
Last updated June 14, 2012
Start date October 2004
Est. completion date January 2014

Study information
Verified date January 2008
Source University Hospital, Gasthuisberg
Contact Chantal Mathieu, M.D., PhD.
Phone 0032/16/346994
Email chantal.mathieu@uz.kuleuven.ac.be
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- kidney pancreas recipients

- kidney recipients

- healthy volunteers

- beta-cell recipients

- immunosuppression with MMF-Tacrolimus

- 1-4 years after transplantation

Exclusion Criteria:

- high doses of steroids

- insulin dependent

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• hyperglycemic clamp test
hyperglycemic clamp test

Locations
Country Name City State
Belgium Department of Endocrinology, Leuven, UZ-Gasthuisberg Leuven

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Gasthuisberg Fund for Scientific Research, Flanders, Belgium, Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary insulin secretion during clamp test time 0 No
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