NCT00618761

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 15, 2012

Status Verified

January 1, 2008

Enrollment Period

9.3 years

First QC Date

February 6, 2008

Last Update Submit

June 14, 2012

Conditions

Kidney TransplantationPancreas Transplantation

Keywords

glucose clampbeta-cell

Outcome Measures

Primary Outcomes (1)

  • insulin secretion during clamp test

    time 0

Study Arms (4)

1

EXPERIMENTAL

kidney-pancreas recipients

Other: hyperglycemic clamp test

2

ACTIVE COMPARATOR

kidney recipients

Other: hyperglycemic clamp test

3

ACTIVE COMPARATOR

healthy controls

Other: hyperglycemic clamp test

4

ACTIVE COMPARATOR

beta-cell recipients

Other: hyperglycemic clamp test

Interventions

hyperglycemic clamp testOTHER

hyperglycemic clamp test

1234

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • kidney pancreas recipients
  • kidney recipients
  • healthy volunteers
  • beta-cell recipients
  • immunosuppression with MMF-Tacrolimus
  • years after transplantation

You may not qualify if:

  • high doses of steroids
  • insulin dependent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Leuven, UZ-Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Study Officials

  • Chantal Mathieu, M.D., PhD

    UZ-Gasthuisberg, Department of Endocrinology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Mathieu, M.D., PhD.

CONTACT

0032/16/346994chantal.mathieu@uz.kuleuven.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

October 1, 2004

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 15, 2012

Record last verified: 2008-01

Locations

BE(1)