PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study
E. Gaiffe,
T. Crepin,
J. Bamoulid,
C. Courivaud,
M. Büchler,
E. Cassuto,
L. Albano,
J. M. Chemouny,
G. Choukroun,
M. Hazzan,
L. Kessler,
C. Legendre,
Y. Le Meur,
N. Ouali,
A. Thierry,
A. Anota,
V. Nerich,
S. Limat,
F. Bonnetain,
D. Vernerey,
D. Ducloux
Affiliations
E. Gaiffe
CHU Besançon, Department of Nephrology, Dialysis, and Renal Transplantation, Federation Hospitalo-Universitaire INCREASE
T. Crepin
CHU Besançon, Department of Nephrology, Dialysis, and Renal Transplantation, Federation Hospitalo-Universitaire INCREASE
J. Bamoulid
CHU Besançon, Department of Nephrology, Dialysis, and Renal Transplantation, Federation Hospitalo-Universitaire INCREASE
C. Courivaud
CHU Besançon, Department of Nephrology, Dialysis, and Renal Transplantation, Federation Hospitalo-Universitaire INCREASE
M. Büchler
CHU Bretonneau, Department of Nephrology and Clinical Immunology, EA 4245 Transplantation, Immunology, Inflammation
E. Cassuto
Pasteur hospital, L’Archet hospital group, Department of Nephrology, Dialysis, and Renal Transplantation
L. Albano
Pasteur hospital, L’Archet hospital group, Department of Nephrology, Dialysis, and Renal Transplantation
J. M. Chemouny
CHU de Rennes, Department of Nephrology
G. Choukroun
CHU Amiens, Department of Nephrology, Dialysis, and Renal Transplantation
M. Hazzan
CHU de Lille, Nephrology department, University of Lille UMR 995
L. Kessler
CHU Strasbourg, Department of Endocrinology, Diabetes and Nutrition
C. Legendre
Necker hospital, Department of Nephrology, Dialysis, and Renal Transplantation
Y. Le Meur
Department of Nephrology, CHU de Brest, UMR1227, Université de Brest, Inserm
N. Ouali
Tenon hospital, Nephrological Emergencies and Kidney Transplantation
A. Thierry
CHU de Poitiers, Department of Nephrology, Dialysis, and Renal Transplantation
A. Anota
INSERM, UMR1098, EFS-BFC, University Burgundy Franche-Comte, LabEx LipSTIC, FHU INCREASE
V. Nerich
INSERM, UMR1098, EFS-BFC, University Burgundy Franche-Comte, LabEx LipSTIC, FHU INCREASE
S. Limat
INSERM, UMR1098, EFS-BFC, University Burgundy Franche-Comte, LabEx LipSTIC, FHU INCREASE
F. Bonnetain
INSERM, UMR1098, EFS-BFC, University Burgundy Franche-Comte, LabEx LipSTIC, FHU INCREASE
D. Vernerey
INSERM, UMR1098, EFS-BFC, University Burgundy Franche-Comte, LabEx LipSTIC, FHU INCREASE
D. Ducloux
CHU Besançon, Department of Nephrology, Dialysis, and Renal Transplantation, Federation Hospitalo-Universitaire INCREASE
Abstract Background Post-transplant diabetes is a frequent and serious complication of kidney transplantation. There is currently no treatment to prevent or delay the disease. Nevertheless, identification of risk factors make it possible to target a population at risk of developing de novo diabetes. We hypothesized that a short-term treatment with vildagliptin may prevent new onset diabetes after transplantation (NODAT) in high-risk patients. Methods/design This is a multicenter, double-blind, placebo-controlled randomized clinical trial. Patients undergoing first kidney transplantation will be included from ten French transplant centers. Included patients will be randomized (1:1) to receive either vildagliptin 100 or 50 mg/day (depending on glomerular filtration rate) during 2 months (the first dose being administered before entering the operating theatres) or placebo. Additional antidiabetic therapy could be administered according to glycemic control. The primary outcome is the proportion of diabetic patients 1 year after transplantation, defined as patients receiving a diabetic treatment, or having a fasting glucose above 7 mmol/l, and/or with an abnormal oral glucose tolerance test. Secondary outcomes include glycated hemoglobin, the occurrence of acute rejection, infection, graft loss and patient death at 3 months, 6 months, and 12 months after transplantation. Outcomes will be correlated to clinical and general characteristics of the patient, cardiovascular history, nephropathy, dialysis history, transplantation data, biological data, health-related quality of life, and the cost-effectiveness of prevention of diabetes with vildagliptin. Discussion We have scarce data on the pharmacological prevention of post-transplant diabetes. If our hypothesis is verified, our results will have a direct application in clinical practice and could limit diabetes-associated morbidity, reduce cardiovascular complications, increase quality of life of renal transplant patients, and consequently promote graft and patient survival. Our results may possibly serve for non-transplant patients carrying a high-risk of diabetes associated with other co-morbidities. Trial registration ClinicalTrials.gov, NCT02849899. Registered on 8 February 2016.