Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective Study

Abstract Background Post-transplant diabetes mellitus (PTDM) beyond 12 months (late PTDM) is a severe complication after renal transplantation. Late PTDM develops mostly in subjects with prediabetes. Although exercise may have a potential role in preventing late PTDM, there are no previous data on t...

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Main Authors: Raúl Morales Febles, Domingo Marrero Miranda, Alejandro Jiménez Sosa, Ana González Rinne, Coriolano Cruz Perera, Ana Elena Rodríguez-Rodríguez, Alejandra Álvarez González, Laura Díaz Martín, Natalia Negrín Mena, Cristian Acosta Sørensen, Lourdes Pérez Tamajón, Aurelio Rodríguez Hernández, Federico González Rinne, Aday Dorta González, Eusebio Ledesma Pérez, Alejandra González Delgado, Alberto Domínguez-Rodríguez, Maria del Carmen García Baute, Armando Torres Ramírez, Esteban Porrini
Format: Article
Language:English
Published: SpringerOpen 2023-05-01
Series:Sports Medicine - Open
Subjects:
Online Access:https://doi.org/10.1186/s40798-023-00574-8
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author Raúl Morales Febles
Domingo Marrero Miranda
Alejandro Jiménez Sosa
Ana González Rinne
Coriolano Cruz Perera
Ana Elena Rodríguez-Rodríguez
Alejandra Álvarez González
Laura Díaz Martín
Natalia Negrín Mena
Cristian Acosta Sørensen
Lourdes Pérez Tamajón
Aurelio Rodríguez Hernández
Federico González Rinne
Aday Dorta González
Eusebio Ledesma Pérez
Alejandra González Delgado
Alberto Domínguez-Rodríguez
Maria del Carmen García Baute
Armando Torres Ramírez
Esteban Porrini
author_facet Raúl Morales Febles
Domingo Marrero Miranda
Alejandro Jiménez Sosa
Ana González Rinne
Coriolano Cruz Perera
Ana Elena Rodríguez-Rodríguez
Alejandra Álvarez González
Laura Díaz Martín
Natalia Negrín Mena
Cristian Acosta Sørensen
Lourdes Pérez Tamajón
Aurelio Rodríguez Hernández
Federico González Rinne
Aday Dorta González
Eusebio Ledesma Pérez
Alejandra González Delgado
Alberto Domínguez-Rodríguez
Maria del Carmen García Baute
Armando Torres Ramírez
Esteban Porrini
author_sort Raúl Morales Febles
collection DOAJ
description Abstract Background Post-transplant diabetes mellitus (PTDM) beyond 12 months (late PTDM) is a severe complication after renal transplantation. Late PTDM develops mostly in subjects with prediabetes. Although exercise may have a potential role in preventing late PTDM, there are no previous data on the effect of exercise in patients with prediabetes. Material and Methods The design was a 12-month exploratory study to test the capacity of exercise in reverting prediabetes in order to prevent late-PTDM. The outcome was the reversibility of prediabetes, assessed every 3 months with oral glucose tolerance tests (OGTT). The protocol included an incremental plan of aerobic and/or strength training as well as an active plan for promoting adherence (telephone calls, digital technology, and visits). A priori, a sample size cannot be calculated which makes this an exploratory analysis. Based on previous studies, the spontaneous reversibility of prediabetes was 30% and the reversibility induced by exercise will account for another 30%, a total reversibility of 60% (p value < 0.05, assuming a potency of 85%). Ad interim analysis was performed during follow-up to test the certainty of this sample calculation. Patients beyond 12 months after renal transplantation with prediabetes were included. Results The study was interrupted early due to efficacy after the evaluation of the follow-up of 27 patients. At the end of follow-up, 16 (60%) patients reverted to normal glucose levels at fasting (from 102.13 mg/dL ± 11 to 86.75 ± 6.9, p = 0.006) and at 120 min after the OGTTs (154.44 mg/dL ± 30 to 113.0 ± 13.1, p = 0.002) and 11 patients had persistent prediabetes (40%). Also, insulin sensitivity improved with the reversibility of prediabetes, compared to those with persistent prediabetes: 0.09 [0.08–0.11] versus 0.04 [0.01–0.07], p = 0.001 (Stumvoll index). Most needed at least one increment in the prescription of exercise and compliance. Finally, measures aimed at the improvement of compliance were successful in 22 (80%) patients. Conclusion Exercise training was effective to improve glucose metabolism in renal transplant patients with prediabetes. Exercise prescription must be conducted considering both the clinical characteristics of the patients and pre-defined strategy to promote adherence. The trial registration number of the study was NCT04489043.
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spelling doaj.art-e05af955a77d440a8894ccbc3371c6962023-05-21T11:17:19ZengSpringerOpenSports Medicine - Open2198-97612023-05-019111310.1186/s40798-023-00574-8Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective StudyRaúl Morales Febles0Domingo Marrero Miranda1Alejandro Jiménez Sosa2Ana González Rinne3Coriolano Cruz Perera4Ana Elena Rodríguez-Rodríguez5Alejandra Álvarez González6Laura Díaz Martín7Natalia Negrín Mena8Cristian Acosta Sørensen9Lourdes Pérez Tamajón10Aurelio Rodríguez Hernández11Federico González Rinne12Aday Dorta González13Eusebio Ledesma Pérez14Alejandra González Delgado15Alberto Domínguez-Rodríguez16Maria del Carmen García Baute17Armando Torres Ramírez18Esteban Porrini19Faculty of Medicine, University of La LagunaNephrology Department, University Hospital of Canary IslandsResearch Unit, University Hospital of Canary IslandsNephrology Department, University Hospital of Canary IslandsResearch Unit, University Hospital of Canary IslandsResearch Unit, University Hospital of Canary IslandsNephrology Department, University Hospital of Canary IslandsResearch Unit, University Hospital of Canary IslandsResearch Unit, University Hospital of Canary IslandsNephrology Department, University Hospital of Canary IslandsNephrology Department, University Hospital of Canary IslandsNephrology Department, University Hospital of Canary IslandsLaboratory of Renal Function (LFR), Faculty of Medicine, University of La LagunaFaculty of Physiotherapy, University of La LagunaFaculty of Physiotherapy, University of La LagunaCentral Laboratory, University Hospital of Canary IslandsCardiology Department, University Hospital of Canary IslandsCardiology Department, University Hospital of Canary IslandsFaculty of Medicine, University of La LagunaFaculty of Medicine, University of La LagunaAbstract Background Post-transplant diabetes mellitus (PTDM) beyond 12 months (late PTDM) is a severe complication after renal transplantation. Late PTDM develops mostly in subjects with prediabetes. Although exercise may have a potential role in preventing late PTDM, there are no previous data on the effect of exercise in patients with prediabetes. Material and Methods The design was a 12-month exploratory study to test the capacity of exercise in reverting prediabetes in order to prevent late-PTDM. The outcome was the reversibility of prediabetes, assessed every 3 months with oral glucose tolerance tests (OGTT). The protocol included an incremental plan of aerobic and/or strength training as well as an active plan for promoting adherence (telephone calls, digital technology, and visits). A priori, a sample size cannot be calculated which makes this an exploratory analysis. Based on previous studies, the spontaneous reversibility of prediabetes was 30% and the reversibility induced by exercise will account for another 30%, a total reversibility of 60% (p value < 0.05, assuming a potency of 85%). Ad interim analysis was performed during follow-up to test the certainty of this sample calculation. Patients beyond 12 months after renal transplantation with prediabetes were included. Results The study was interrupted early due to efficacy after the evaluation of the follow-up of 27 patients. At the end of follow-up, 16 (60%) patients reverted to normal glucose levels at fasting (from 102.13 mg/dL ± 11 to 86.75 ± 6.9, p = 0.006) and at 120 min after the OGTTs (154.44 mg/dL ± 30 to 113.0 ± 13.1, p = 0.002) and 11 patients had persistent prediabetes (40%). Also, insulin sensitivity improved with the reversibility of prediabetes, compared to those with persistent prediabetes: 0.09 [0.08–0.11] versus 0.04 [0.01–0.07], p = 0.001 (Stumvoll index). Most needed at least one increment in the prescription of exercise and compliance. Finally, measures aimed at the improvement of compliance were successful in 22 (80%) patients. Conclusion Exercise training was effective to improve glucose metabolism in renal transplant patients with prediabetes. Exercise prescription must be conducted considering both the clinical characteristics of the patients and pre-defined strategy to promote adherence. The trial registration number of the study was NCT04489043.https://doi.org/10.1186/s40798-023-00574-8Renal transplantationPost-transplant diabetes mellitusPrediabetesExercise and adherence
spellingShingle Raúl Morales Febles
Domingo Marrero Miranda
Alejandro Jiménez Sosa
Ana González Rinne
Coriolano Cruz Perera
Ana Elena Rodríguez-Rodríguez
Alejandra Álvarez González
Laura Díaz Martín
Natalia Negrín Mena
Cristian Acosta Sørensen
Lourdes Pérez Tamajón
Aurelio Rodríguez Hernández
Federico González Rinne
Aday Dorta González
Eusebio Ledesma Pérez
Alejandra González Delgado
Alberto Domínguez-Rodríguez
Maria del Carmen García Baute
Armando Torres Ramírez
Esteban Porrini
Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective Study
Sports Medicine - Open
Renal transplantation
Post-transplant diabetes mellitus
Prediabetes
Exercise and adherence
title Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective Study
title_full Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective Study
title_fullStr Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective Study
title_full_unstemmed Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective Study
title_short Exercise and Prediabetes After Renal Transplantation (EXPRED-I): A Prospective Study
title_sort exercise and prediabetes after renal transplantation expred i a prospective study
topic Renal transplantation
Post-transplant diabetes mellitus
Prediabetes
Exercise and adherence
url https://doi.org/10.1186/s40798-023-00574-8
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