Nephrologic Prognosis 10 Years After Diabetes Cell Therapy | NCT02627690

Studies
Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

NCT02627690

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Apr 29, 2022Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Islet Transplantation

Interventions

islet transplanted
non islet transplanted

Countries

France

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
2014-A00141-46	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2014Actual

Primary Completion Date

Nov 29, 2021Actual

Completion Date

Nov 29, 2021Actual

First Submitted Date

Feb 5, 2015

First Submission Date that Met QC Criteria

Dec 8, 2015

First Posted Date

Dec 11, 2015Estimated

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

Apr 28, 2022

Last Update Posted Date

Apr 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Islet transplantation for type 1 diabetes results are still improving, and actually Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological interventions to inject islets, an immunosuppressive regimen is needed, which can be deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet transplantation on stabilization or prevention of macro and micro vascular complications of diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or improvement of microvascular complications when compared to pre-transplant data.

The aim of this study is to compare the evolution of diabetes complications, especially nephrologic, 10 years after islet transplantation and to compare it to patients with a brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed.

This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of type 1 diabetes) before islet transplantation and 10 years after the transplantation or after the first evaluation in patients who finally did not underwent islet transplantation for various non nephrologic reasons

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Islet transplanted		patients who underwent islet transplantation	Other: islet transplanted
non islet transplanted		patients who refused or were non selected for islet transplantation for a non nephrologic reason	Other: non islet transplanted

Interventions

Name	Type	Description	Arm Group Labels	Other Names
islet transplanted	Other	islet transplantation	Islet transplanted	Islet transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modification of Diet in Renal Disease (MDRD)	measure the difference of Modification of Diet in Renal Disease (MDRD) between the two groups according to the presence or absence of an islet transplant.	At 10 years

Secondary Outcomes

Measure	Description	Time Frame
number of cardiovascular events		At 10 years
number of deaths		At 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetic patients, with or without previous renal transplantation who benefit at least 5 years before the inclusion of clinical evaluation in order to perform an islet transplantation
Who either benefit of islet transplantation or did not and treated with optimized insulin therapy

Exclusion Criteria:

C-peptide positive diabetes
Type 1 diabetic patient non-grafted of islets due to albuminuria> 300mg / 24h or MDRD <50 ml / min during the pre-transplant evaluation (exclusion criterion for islet transplantation)
Patients that can not receive clear information
Refusal to sign the consent
Psychiatric Pathology
Participation in another study excluding the possibility of participating in another protocol.
Pregnant or breast feeding women
Patients under guardianship, persons deprived of freedom
Lack of coverage by the social security system

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

77 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering of type 1 diabetes since at least 10 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Christine VANTYGHEM, MD, PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lille University Hospital		Lille		59037	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016381	Islets of Langerhans Transplantation

Ancestor Terms

ID	Term
D017690	Cell Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

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Browse Branches

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