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Sponsors and Collaborators: |
University Hospital, Gasthuisberg Juvenile Diabetes Research Foundation Fund for Scientific Research, Flanders, Belgium |
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Information provided by: | University Hospital, Gasthuisberg |
ClinicalTrials.gov Identifier: | NCT00618761 |
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.
Condition | Intervention |
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Kidney Transplantation Pancreas Transplantation |
Other: hyperglycemic clamp test |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Parallel Assignment |
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. |
Estimated Enrollment: | 40 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
kidney-pancreas recipients
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Other: hyperglycemic clamp test
hyperglycemic clamp test
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2: Active Comparator
kidney recipients
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Other: hyperglycemic clamp test
hyperglycemic clamp test
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3: Active Comparator
healthy controls
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Other: hyperglycemic clamp test
hyperglycemic clamp test
|
4: Active Comparator
beta-cell recipients
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Other: hyperglycemic clamp test
hyperglycemic clamp test
|
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chantal Mathieu, M.D., PhD. | 0032/16/346994 | chantal.mathieu@uz.kuleuven.ac.be |
Belgium | |
Department of Endocrinology, Leuven, UZ-Gasthuisberg | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Pieter Gillard, M.D. 003216346994 pieter.gillard@uz.kuleuven.ac.be | |
Sub-Investigator: Pieter Gillard, M.D. |
Principal Investigator: | Chantal Mathieu, M.D., PhD | UZ-Gasthuisberg, Department of Endocrinology |
Responsible Party: | department of endocrinology, UZ Gasthuisberg, Leuven ( Prof. Dr. Chantal Mathieu ) |
Study ID Numbers: | clamp01, JDRF 4/2005/1327 |
Study First Received: | February 6, 2008 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00618761 |
Health Authority: | Belgium: Institutional Review Board |
glucose clamp beta-cell |
Healthy Pancrelipase Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |