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Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study

AIMS/INTRODUCTION: To investigate the long‐term efficacy and safety of islet transplantation (ITx) compared with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). MATERIALS AND METHODS: Among 619 patients diagnosed as insulin‐dependent diabetes mellitus or type 1 di...

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Autores principales: Nakamura, Toshihiro, Fujikura, Junji, Anazawa, Takayuki, Ito, Ryo, Ogura, Masahito, Okajima, Hideaki, Uemoto, Shinji, Inagaki, Nobuya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078128/
https://www.ncbi.nlm.nih.gov/pubmed/31390159
http://dx.doi.org/10.1111/jdi.13128
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author Nakamura, Toshihiro
Fujikura, Junji
Anazawa, Takayuki
Ito, Ryo
Ogura, Masahito
Okajima, Hideaki
Uemoto, Shinji
Inagaki, Nobuya
author_facet Nakamura, Toshihiro
Fujikura, Junji
Anazawa, Takayuki
Ito, Ryo
Ogura, Masahito
Okajima, Hideaki
Uemoto, Shinji
Inagaki, Nobuya
author_sort Nakamura, Toshihiro
collection PubMed
description AIMS/INTRODUCTION: To investigate the long‐term efficacy and safety of islet transplantation (ITx) compared with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). MATERIALS AND METHODS: Among 619 patients diagnosed as insulin‐dependent diabetes mellitus or type 1 diabetes at Kyoto University, Kyoto, Japan, seven patients were selected as the ITx group and 26 age‐matched patients with no endogenous insulin secretion were selected as the MDI/CSII group. Hemoglobin A1c, aspartate aminotransferase/alanine aminotransferase (AST/ALT) and creatinine were assessed retrospectively at 1, 2, 5 and 10 years for both groups; serum C‐peptide immunoreactivity was assessed for the ITx group. Major clinical events were also assessed. RESULTS: Hemoglobin A1c improvement in ITx was significant at 1 year (8.4% [7.8–9.9%] at baseline to 7.1% [6.3–7.4%] in ITx vs 8.2% [7.4–9.8%] at baseline to 8.1% [7.3–9.5%] in MDI/CSII, P < 0.01 between groups), and was maintained at 2 years (7.4% [6.3–8.2%] vs 8.4% [7.4–9.6%], P = 0.11). The increase of stimulated C‐peptide immunoreactivity was significant at 1 year (0.57 ng/mL [0.26–0.99 ng/mL], P < 0.05 from baseline) and 2 years (0.43 ng/mL [0.19–0.67 ng/mL], P < 0.05), although it became insignificant thereafter. There was no significant difference in AST/ALT or creatinine at 10 years, although a transient AST/ALT elevation was observed in ITx. In regard to clinical events, the occurrence of severe hypoglycemia was 14% vs 31% (relative risk 0.46, P = 0.64), that of infectious disease was 43% vs 12% (relative risk 3.71, P = 0.09) and digestive symptoms was 43% vs 7.7% (relative risk 5.57, P = 0.05) in ITx vs MDI/CSII, respectively. No patient died in either group. CONCLUSIONS: The present findings showed that ITx was considered to contribute to the reduction of hypoglycemia and better glycemic control with tolerable, but attention‐requiring, risks over a period of 10 years compared with MDI/CSII.
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spelling pubmed-70781282020-03-19 Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study Nakamura, Toshihiro Fujikura, Junji Anazawa, Takayuki Ito, Ryo Ogura, Masahito Okajima, Hideaki Uemoto, Shinji Inagaki, Nobuya J Diabetes Investig Articles AIMS/INTRODUCTION: To investigate the long‐term efficacy and safety of islet transplantation (ITx) compared with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). MATERIALS AND METHODS: Among 619 patients diagnosed as insulin‐dependent diabetes mellitus or type 1 diabetes at Kyoto University, Kyoto, Japan, seven patients were selected as the ITx group and 26 age‐matched patients with no endogenous insulin secretion were selected as the MDI/CSII group. Hemoglobin A1c, aspartate aminotransferase/alanine aminotransferase (AST/ALT) and creatinine were assessed retrospectively at 1, 2, 5 and 10 years for both groups; serum C‐peptide immunoreactivity was assessed for the ITx group. Major clinical events were also assessed. RESULTS: Hemoglobin A1c improvement in ITx was significant at 1 year (8.4% [7.8–9.9%] at baseline to 7.1% [6.3–7.4%] in ITx vs 8.2% [7.4–9.8%] at baseline to 8.1% [7.3–9.5%] in MDI/CSII, P < 0.01 between groups), and was maintained at 2 years (7.4% [6.3–8.2%] vs 8.4% [7.4–9.6%], P = 0.11). The increase of stimulated C‐peptide immunoreactivity was significant at 1 year (0.57 ng/mL [0.26–0.99 ng/mL], P < 0.05 from baseline) and 2 years (0.43 ng/mL [0.19–0.67 ng/mL], P < 0.05), although it became insignificant thereafter. There was no significant difference in AST/ALT or creatinine at 10 years, although a transient AST/ALT elevation was observed in ITx. In regard to clinical events, the occurrence of severe hypoglycemia was 14% vs 31% (relative risk 0.46, P = 0.64), that of infectious disease was 43% vs 12% (relative risk 3.71, P = 0.09) and digestive symptoms was 43% vs 7.7% (relative risk 5.57, P = 0.05) in ITx vs MDI/CSII, respectively. No patient died in either group. CONCLUSIONS: The present findings showed that ITx was considered to contribute to the reduction of hypoglycemia and better glycemic control with tolerable, but attention‐requiring, risks over a period of 10 years compared with MDI/CSII. John Wiley and Sons Inc. 2019-09-17 2020-03 /pmc/articles/PMC7078128/ /pubmed/31390159 http://dx.doi.org/10.1111/jdi.13128 Text en © 2019 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Articles
Nakamura, Toshihiro
Fujikura, Junji
Anazawa, Takayuki
Ito, Ryo
Ogura, Masahito
Okajima, Hideaki
Uemoto, Shinji
Inagaki, Nobuya
Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study
title Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study
title_full Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study
title_fullStr Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study
title_full_unstemmed Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study
title_short Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study
title_sort long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: an observational cohort study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078128/
https://www.ncbi.nlm.nih.gov/pubmed/31390159
http://dx.doi.org/10.1111/jdi.13128
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