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

NCT ID: NCT00618761

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplantation Pancreas Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

kidney-pancreas recipients

Group Type EXPERIMENTAL

hyperglycemic clamp test

Intervention Type OTHER

hyperglycemic clamp test

2

kidney recipients

Group Type ACTIVE_COMPARATOR

hyperglycemic clamp test

Intervention Type OTHER

hyperglycemic clamp test

3

healthy controls

Group Type ACTIVE_COMPARATOR

hyperglycemic clamp test

Intervention Type OTHER

hyperglycemic clamp test

4

beta-cell recipients

Group Type ACTIVE_COMPARATOR

hyperglycemic clamp test

Intervention Type OTHER

hyperglycemic clamp test

Interventions

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hyperglycemic clamp test

hyperglycemic clamp test

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Responsible Party

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Pieter Gillard

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chantal Mathieu, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

UZ-Gasthuisberg, Department of Endocrinology

Locations

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Department of Endocrinology, Leuven, UZ-Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Chantal Mathieu, M.D., PhD.

Role: CONTACT

0032/16/346994

Facility Contacts

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Pieter Gillard, M.D.

Role: primary

003216346994

Other Identifiers

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JDRF 4/2005/1327

Identifier Type: -

Identifier Source: secondary_id

clamp01

Identifier Type: -

Identifier Source: org_study_id

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