Informations générales (source: ClinicalTrials.gov)
Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients (GLITTER)
Interventional
Phase 4
Centre Hospitalier Departemental Vendee (Voir sur ClinicalTrials)
mars 2019
juillet 2026
04 avril 2025
Diabetes after kidney transplantation is a frequent complication, the incidence of which
varies from 7 to 45% depending on the studies and on the diagnostic criteria used.
Post-transplant diabetes is an early complication, most often occurring in the first
month after transplantation.
In addition to the additional health costs generated by the appearance of post-transplant
diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by
90%. Similarly, the development of glucose intolerance after transplantation is
associated with higher mortality.
Tacrolimus treatment is therefore currently one of the most important risk factors for
diabetes at the time of transplantation.
Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters
pancreatic endocrine function.
In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the
rise in capillary or venous blood sugar levels after transplantation. This diabetes often
requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable
period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying
preventive treatment.
No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin
resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β%
and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to
estimate insulin secretion and insulin resistance in fasting patients respectively, while
the oral glucose disposition index (IDO) makes it possible to study insulin secretion and
action dynamically (after a 75 g glucose load), and are calculated as follows:
HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x
fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta
insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0
These indices have already been studied in dialysis patients (diabetic and non-diabetic)
and may allow a more detailed study of pancreatic response and insulin resistance under
tacrolimus in patients prior to renal transplantation. Determining the "pancreatic
response" to tacrolimus in patients prior to transplantation would prevent diabetes by
adapting immunosuppressive treatment and post-transplant screening modalities in the
event of pre-transplant subclinical abnormalities identified in our study. The
development of tacrolimus-induced diabetes in pre-transplantation in our study will be a
contraindication to tacrolimus at the time of transplantation and ciclosporin therapy
will be preferred.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Départemental Vendée - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire Nantes - Nantes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years
- Patient eligible for kidney transplantation at the Nantes University Hospital
- Hemodialysis patient in one of the participating centres
- Patient who is able to understand the proposed protocol and has given free and
informed consent
- Patient with affiliation to the French social security system.
- Age ≥ 18 years
- Patient eligible for kidney transplantation at the Nantes University Hospital
- Hemodialysis patient in one of the participating centres
- Patient who is able to understand the proposed protocol and has given free and
informed consent
- Patient with affiliation to the French social security system.
- Personal history of diabetes treated or untreated
- Temporary contraindication for carcinological reasons
- Immunosuppressive treatment in the 6 months prior to inclusion
- Macrolide Allergies
- Hypersensitivity to the excipients used in the composition of tacrolimus
- Intolerance to the HGPO test
- Progressive infectious outbreak
- Hepatic insufficiency
- Intercurrent infectious pathology
- Patient under guardianship, curatorship, legal protection measure, or deprived of
liberty
- Pregnant women, breastfeeding, or non-menopausal woman who refuses contraception