Islet TransplantationPRONOCELDIABNCT02627690
Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
An observational study of Islet Transplantation, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Islet Transplantation
- What is being tested?
- islet transplanted and non islet transplanted
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2014to 29 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering of type 1 diabetes since at least 10 years
Who may be able to join
- 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
Who cannot join
- 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.
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- Pregnant or breast feeding women
- Patients under guardianship, persons deprived of freedom
- Lack of coverage by the social security system
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Islet Transplantation
- Being tested
- islet transplanted, non islet transplanted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
islet transplantedOther
Also called Islet transplantation
islet transplantation
non islet transplantedOther
Also called no islet transplantation
no islet transplantation (for a non nephrologic reason)
| Study group | Role | What they receive |
|---|---|---|
| Islet transplanted | patients who underwent islet transplantation Receives: Other: islet transplanted | |
| non islet transplanted | patients who refused or were non selected for islet transplantation for a non nephrologic reason Receives: Other: non islet transplanted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 10 years
Secondary outcomes (2)
number of cardiovascular events
Measured: At 10 years
number of deaths
Measured: At 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start3 Nov 2014
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Islet TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine VANTYGHEM, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627690
- Sponsor's protocol ID
- 2013_28
- Other IDs
- 2014-A00141-46
- Acronym
- PRONOCELDIAB
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2015
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
- ClinicalTrials.gov ID
- NCT02627690
- Acronym / sponsor ID
- PRONOCELDIAB / 2013_28
- Conditions
- Islet Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Islet transplanted | – | Other: islet transplantedpatients who underwent islet transplantation |
| non islet transplanted | – | Other: non islet transplantedpatients who refused or were non selected for islet transplantation for a non nephrologic reason |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering of type 1 diabetes since at least 10 years
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| islet transplantedAlso: Islet transplantationislet transplantation | Other | Islet transplanted |
| non islet transplantedAlso: no islet transplantationno islet transplantation (for a non nephrologic reason) | Other | non islet transplanted |
Primary outcome
Modification of Diet in Renal Disease (MDRD)
Time frame: At 10 years
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.
2 secondary outcomes
number of cardiovascular events
Time frame: At 10 years
number of deaths
Time frame: At 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Islet Transplantation
Active, not recruitingPhase 1
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
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Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
RecruitingPhase 1/2
Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
Diabetes Mellitus, Type 1
Active, not recruitingPhase 1/2
Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D)
Type 1 Diabetes Mellitus
Active, not recruitingPhase 1
Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
Chronic Pancreatitis, Mesenchymal Stem Cells
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Christine VANTYGHEM, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Islet Transplantation, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of Diet in Renal Disease (MDRD) (time frame: At 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.