Insulin Secretory Capacity in Insulin-independent Pancrea... | NCT00618761

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

NCT00618761

Sponsor

University Hospital, Gasthuisberg

Status

Unknown status

Last Update Posted

Jun 15, 2012Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Kidney Transplantation
Pancreas Transplantation

Interventions

hyperglycemic clamp test

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
JDRF 4/2005/1327

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Feb 6, 2008

First Submission Date that Met QC Criteria

Feb 6, 2008

First Posted Date

Feb 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2012

Last Update Posted Date

Jun 15, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pieter Gillard, Prof Dr, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

University Hospital, GasthuisbergOTHER

Collaborators

Name	Class
Juvenile Diabetes Research Foundation	OTHER
Fund for Scientific Research, Flanders, Belgium	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
hyperglycemic clamp test	Other	hyperglycemic clamp test	1 2 3 4

Measure	Description	Time Frame
insulin secretion during clamp test		time 0

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chantal Mathieu, M.D., PhD.	Contact	0032/16/346994		chantal.mathieu@uz.kuleuven.ac.be

Overall Officials

Name	Affiliation	Role
Chantal Mathieu, M.D., PhD	UZ-Gasthuisberg, Department of Endocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Leuven, UZ-Gasthuisberg	Recruiting	Leuven		3000	Belgium