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

This study is currently recruiting participants.

Verified by University Hospital, Gasthuisberg, January 2008

First Received: February 6, 2008 No Changes Posted

Sponsor:	University Hospital, Gasthuisberg
Collaborators:	Juvenile Diabetes Research Foundation Fund for Scientific Research, Flanders, Belgium
Information provided by:	University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:	NCT00618761

Purpose

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
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.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation Pancreas Transplantation

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:

insulin secretion during clamp test [ Time Frame: date of inclusion ] [ Designated as safety issue: No ]

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
1: Experimental kidney-pancreas recipients	Other: hyperglycemic clamp test hyperglycemic clamp test
2: Active Comparator kidney recipients	Other: hyperglycemic clamp test hyperglycemic clamp test
3: Active Comparator healthy controls	Other: hyperglycemic clamp test hyperglycemic clamp test
4: Active Comparator beta-cell recipients	Other: hyperglycemic clamp test hyperglycemic clamp test

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618761

Contacts

Contact: Chantal Mathieu, M.D., PhD.

0032/16/346994

chantal.mathieu@uz.kuleuven.ac.be

Locations

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.

Sponsors and Collaborators

University Hospital, Gasthuisberg

Juvenile Diabetes Research Foundation

Fund for Scientific Research, Flanders, Belgium

Investigators

Principal Investigator:

Chantal Mathieu, M.D., PhD

UZ-Gasthuisberg, Department of Endocrinology

More Information

No publications provided

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 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:

glucose clamp
beta-cell

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010