Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement (MULT-ILOT)
21. juni 2026 oppdatert av: University Hospital, Montpellier
Efficacy and Safety of Islet Re-transplantation After Failure of Beta-cell Replacement
Islet transplantation and pancreas transplantation are established therapeutic options for selected individuals with type 1 diabetes experiencing severe glycemic instability and recurrent hypoglycemia. Although these approaches significantly improve glycemic management and quality of life, long-term graft survival remains limited, with a progressive decline in beta-cell function over time.
The clinical benefit-risk profile of islet re-transplantation after graft failure remains poorly defined, and outcomes following repeat islet transplantation after prior islet graft failure have not been specifically evaluated.
Repeated exposure to multiple donors may increase the risk of alloimmunization, including the development of donor-specific antibodies , which may adversely affect graft survival and limit access to future transplantation.
This multicenter retrospective cohort study aims to evaluate the efficacy and safety of islet re-transplantation in adults with type 1 diabetes after failure of initial beta-cell replacement (islet or pancreas transplantation), with outcomes assessed at 3 months, 1 year, and 5 years.
Studieoversikt
Status
Rekruttering
Studietype
Observasjonsmessig
Registrering (Antatt)
20
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Orianne OV Villard, MD
- Telefonnummer: +33 467 338 382
- E-post: orianne.villard@chu-montpellier.fr
Studer Kontakt Backup
- Navn: Roxane RD Descaillot
- E-post: roxanedescaillot@gmail.com
Studiesteder
-
-
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Montpellier, Frankrike, 34000
- Rekruttering
- Montpellier University Hospital
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Ta kontakt med:
- Orianne OV Villard, MD
- Telefonnummer: +33 467 338 382
- E-post: orianne.villard@chu-montpellier.fr
-
Hovedetterforsker:
- Orianne OV Villard, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Adults with type 1 diabetes who underwent prior beta-cell replacement therapy (pancreas or islet transplantation) and subsequent islet re-transplantation after graft failure.
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of type 1 diabetes
- Prior beta-cell replacement therapy : islet transplantation or pancreas transplantation
- Islet re-transplantation performed after 2005
- Islet re-transplantation performed after documented beta cell graft failure, defined by undetectable C-peptide and/or recurrence of severe hypoglycemia on insulin therapy
- Availability of clinical and biological data required for assessment of study outcomes
Exclusion Criteria:
- Missing or incomplete data preventing assessment of the primary outcome
- Patients who did not meet inclusion criteria
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Initial pancreas transplant
Islet after pancreas transplant failure
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Initial islet transplant
Islet after islet transplant failure
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Islet graft success
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Assessed using Igls criteria (optimal or good graft function classification) based on C-peptide, insulin use, hemoglobin A1c, and severe hypoglycemia
|
Baseline, 3 months, 1 year, 5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Glycemic Control_Glycated hemoglobin (HbA1c) level
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
HbA1c level, measured by HPLC method
|
Baseline, 3 months, 1 year, 5 years
|
|
Glycemic Control_Percentage of individuals with HbA1c < 7% and no severe hypoglycemia
Tidsramme: Baseline, 3 months, 12 months, 5 years
|
Baseline, 3 months, 12 months, 5 years
|
|
|
Beta-Cell Function_BETA-2 score
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Derived from fasting glucose, paired fasting C-peptide, insulin dose and Hba1c and generates a single value between 0 and 42
|
Baseline, 3 months, 1 year, 5 years
|
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Beta-Cell Function_BETA score
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Derived from fasting glucose, HbA1c, stimulated C-peptide, and absence of insulin or oral hypoglycemic agent use and generates a single value between 0 and 8
|
Baseline, 3 months, 1 year, 5 years
|
|
Beta-Cell Function_Severe hypoglycemia events
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Percentage of individual with severe hypoglycemia events
|
Baseline, 3 months, 1 year, 5 years
|
|
Beta-Cell Function_Residual beta cell function
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Percentage of individual with fasting plasma C-peptide > 0.3 ng/mL
|
Baseline, 3 months, 1 year, 5 years
|
|
Immunological Outcomes_Donor-specific antibodies (DSA)
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Presence and specificity of donor-specific antibodies (DSA) with classification :
|
Baseline, 3 months, 1 year, 5 years
|
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Immunological Outcomes_Autoantibodies
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Dosage of antibodies anti-GAD, anti-IA2, anti-insulin, and anti-ZnT8
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Baseline, 3 months, 1 year, 5 years
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Safety of islet re-transplantation_Procedural complications of islet infusions
Tidsramme: Baseline, 3 months, 1 year, 5 years
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Reported of procedural complications of islet infusions such as portal thrombosis, hematoma, transfusion requirement
|
Baseline, 3 months, 1 year, 5 years
|
|
Safety of islet re-transplantation_Renal function eGFR
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Estimated GFR from serum creatinine level
|
Baseline, 3 months, 1 year, 5 years
|
|
Safety of islet re-transplantation_Albuminuria
Tidsramme: Baseline, 3 months, 1 year, 5 years
|
Measurement of albuminuria or proteinuria
|
Baseline, 3 months, 1 year, 5 years
|
|
Safety of islet re-transplantation_Immunosuppression-related complications
Tidsramme: 3 months, 1 year, 5 years
|
Reported immunosuppression-related complications such as infections ; malignancy, cardiovascular events
|
3 months, 1 year, 5 years
|
|
Safety of islet re-transplantation_Mortality
Tidsramme: 3 months, 1 year, 5 years
|
Patient death
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3 months, 1 year, 5 years
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Glycemic control_Time in range (70-180 mg/dL)
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 180 mg/dL
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Time in tight range (70-140 mg/dL)
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 140 mg/dL
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Time below range 70 mg/dL
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 70 and 54 mg/dL
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Time below range 54 mg/dL
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose below 54 mg/dL
|
Baseline, 3 months, 1 year and 5 years
|
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Glycemic control_Time above range 180 mg/dL
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose between 180 and 250 mg/dL
|
Baseline, 3 months, 1 year and 5 years
|
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Glycemic control_Time above range 250 mg/dL
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) measured time with glucose above 250 mg/dL
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Mean glucose
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Coefficient of variation
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Glycemic risk index
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
|
Baseline, 3 months, 1 year and 5 years
|
|
Glycemic control_Glucose Management Indicator (GMI)
Tidsramme: Baseline, 3 months, 1 year and 5 years
|
Continuous Glucose Monitoring (CGM) derived-metrics
|
Baseline, 3 months, 1 year and 5 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Chetboun M, Drumez E, Ballou C, Maanaoui M, Payne E, Barton F, Kerr-Conte J, Vantyghem MC, Piemonti L, Rickels MR, Labreuche J, Pattou F; Collaborative Islet Transplant Registry (CITR) Investigators study group. Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry. Lancet Diabetes Endocrinol. 2023 Jun;11(6):391-401. doi: 10.1016/S2213-8587(23)00082-7. Epub 2023 Apr 24.
- Maanaoui M, Chetboun M, Top I, Elsermans V, Kerr-Conte J, Le Mapihan K, Defrance F, Gmyr V, Hubert T, Labalette M, Hazzan M, Vantyghem MC, Pattou F. The challenge of HLA donor specific antibodies in the management of pancreatic islet transplantation: an illustrative case-series. Sci Rep. 2022 Jul 21;12(1):12463. doi: 10.1038/s41598-022-16782-3.
- Wojtusciszyn A, Branchereau J, Esposito L, Badet L, Buron F, Chetboun M, Kessler L, Morelon E, Berney T, Pattou F, Benhamou PY, Vantyghem MC; TREPID group. Indications for islet or pancreatic transplantation: Statement of the TREPID working group on behalf of the Societe francophone du diabete (SFD), Societe francaise d'endocrinologie (SFE), Societe francophone de transplantation (SFT) and Societe francaise de nephrologie - dialyse - transplantation (SFNDT). Diabetes Metab. 2019 Jun;45(3):224-237. doi: 10.1016/j.diabet.2018.07.006. Epub 2018 Sep 14.
- Rickels MR, Stock PG, de Koning EJP, Piemonti L, Pratschke J, Alejandro R, Bellin MD, Berney T, Choudhary P, Johnson PR, Kandaswamy R, Kay TWH, Keymeulen B, Kudva YC, Latres E, Langer RM, Lehmann R, Ludwig B, Markmann JF, Marinac M, Odorico JS, Pattou F, Senior PA, Shaw JAM, Vantyghem MC, White S. Defining Outcomes for beta-cell Replacement Therapy in the Treatment of Diabetes: A Consensus Report on the Igls Criteria From the IPITA/EPITA Opinion Leaders Workshop. Transplantation. 2018 Sep;102(9):1479-1486. doi: 10.1097/TP.0000000000002158.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. juli 2025
Primær fullføring (Antatt)
30. september 2026
Studiet fullført (Antatt)
30. september 2026
Datoer for studieregistrering
Først innsendt
9. juni 2026
Først innsendt som oppfylte QC-kriteriene
21. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-06-290
- A111/2025-06-290/001 (Annen identifikator: Scientific and ethics committee of the Montpellier University Hospital)
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