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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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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John Wiley and Sons Inc.
2019
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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. |
format | Online Article Text |
id | pubmed-7078128 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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