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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by University Hospital, Gasthuisberg. Recruitment status was Recruiting

First Received on 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:	Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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: Diabetes Medicines Kidney Transplantation Pancreas Transplantation

Drug Information available for: Insulin Insulin beef Pancrelipase Ultrase

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
Experimental: 1 kidney-pancreas recipients	Other: hyperglycemic clamp test hyperglycemic clamp test
Active Comparator: 2 kidney recipients	Other: hyperglycemic clamp test hyperglycemic clamp test
Active Comparator: 3 healthy controls	Other: hyperglycemic clamp test hyperglycemic clamp test
Active Comparator: 4 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:	Prof. Dr. Chantal Mathieu, department of endocrinology, UZ Gasthuisberg, Leuven
ClinicalTrials.gov Identifier:	NCT00618761 History of Changes
Other Study ID Numbers:	clamp01, JDRF 4/2005/1327
Study First Received:	February 6, 2008
Last Updated:	February 6, 2008
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:

glucose clamp
beta-cell

Additional relevant MeSH terms:

Insulin
Pancrelipase
Hypoglycemic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012