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

June 14, 2012 updated by: Pieter Gillard, University Hospital, Gasthuisberg

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Department of Endocrinology, Leuven, UZ-Gasthuisberg
        • Contact:
        • Sub-Investigator:
          • Pieter Gillard, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin secretion during clamp test
Time Frame: time 0
time 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Collaborators

Juvenile Diabetes Research Foundation
Fund for Scientific Research, Flanders, Belgium

Investigators

  • Principal Investigator: Chantal Mathieu, M.D., PhD, UZ-Gasthuisberg, Department of Endocrinology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • clamp01
  • JDRF 4/2005/1327

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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