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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

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 hypo...

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Autores principales: Gaiffe, E., Crepin, T., Bamoulid, J., Courivaud, C., Büchler, M., Cassuto, E., Albano, L., Chemouny, J. M., Choukroun, G., Hazzan, M., Kessler, L., Legendre, C., Le Meur, Y., Ouali, N., Thierry, A., Anota, A., Nerich, V., Limat, S., Bonnetain, F., Vernerey, D., Ducloux, D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6588872/
https://www.ncbi.nlm.nih.gov/pubmed/31227028
http://dx.doi.org/10.1186/s13063-019-3392-6
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author Gaiffe, E.
Crepin, T.
Bamoulid, J.
Courivaud, C.
Büchler, M.
Cassuto, E.
Albano, L.
Chemouny, J. M.
Choukroun, G.
Hazzan, M.
Kessler, L.
Legendre, C.
Le Meur, Y.
Ouali, N.
Thierry, A.
Anota, A.
Nerich, V.
Limat, S.
Bonnetain, F.
Vernerey, D.
Ducloux, D.
author_facet Gaiffe, E.
Crepin, T.
Bamoulid, J.
Courivaud, C.
Büchler, M.
Cassuto, E.
Albano, L.
Chemouny, J. M.
Choukroun, G.
Hazzan, M.
Kessler, L.
Legendre, C.
Le Meur, Y.
Ouali, N.
Thierry, A.
Anota, A.
Nerich, V.
Limat, S.
Bonnetain, F.
Vernerey, D.
Ducloux, D.
author_sort Gaiffe, E.
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3392-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-65888722019-07-08 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 Gaiffe, E. Crepin, T. Bamoulid, J. Courivaud, C. Büchler, M. Cassuto, E. Albano, L. Chemouny, J. M. Choukroun, G. Hazzan, M. Kessler, L. Legendre, C. Le Meur, Y. Ouali, N. Thierry, A. Anota, A. Nerich, V. Limat, S. Bonnetain, F. Vernerey, D. Ducloux, D. Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3392-6) contains supplementary material, which is available to authorized users. BioMed Central 2019-06-21 /pmc/articles/PMC6588872/ /pubmed/31227028 http://dx.doi.org/10.1186/s13063-019-3392-6 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Gaiffe, E.
Crepin, T.
Bamoulid, J.
Courivaud, C.
Büchler, M.
Cassuto, E.
Albano, L.
Chemouny, J. M.
Choukroun, G.
Hazzan, M.
Kessler, L.
Legendre, C.
Le Meur, Y.
Ouali, N.
Thierry, A.
Anota, A.
Nerich, V.
Limat, S.
Bonnetain, F.
Vernerey, D.
Ducloux, D.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6588872/
https://www.ncbi.nlm.nih.gov/pubmed/31227028
http://dx.doi.org/10.1186/s13063-019-3392-6
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