Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study
Abstract 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 ty...
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doaj-4b8267749cc949eaa2d6d4d131fa240f2021-05-02T06:31:54ZengWileyJournal of Diabetes Investigation2040-11162040-11242020-03-0111236337210.1111/jdi.13128Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort studyToshihiro Nakamura0Junji Fujikura1Takayuki Anazawa2Ryo Ito3Masahito Ogura4Hideaki Okajima5Shinji Uemoto6Nobuya Inagaki7Department of Diabetes, Endocrinology and Nutrition Graduate School of Medicine Kyoto University Kyoto JapanDepartment of Diabetes, Endocrinology and Nutrition Graduate School of Medicine Kyoto University Kyoto JapanDivision of Hepato‐Biliary‐Pancreatic Surgery and Transplantation Graduate School of Medicine Kyoto University Kyoto JapanDepartment of Diabetes, Endocrinology and Nutrition Graduate School of Medicine Kyoto University Kyoto JapanDepartment of Diabetes, Endocrinology and Nutrition Graduate School of Medicine Kyoto University Kyoto JapanDivision of Hepato‐Biliary‐Pancreatic Surgery and Transplantation Graduate School of Medicine Kyoto University Kyoto JapanDivision of Hepato‐Biliary‐Pancreatic Surgery and Transplantation Graduate School of Medicine Kyoto University Kyoto JapanDepartment of Diabetes, Endocrinology and Nutrition Graduate School of Medicine Kyoto University Kyoto JapanAbstract 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.https://doi.org/10.1111/jdi.13128Insulin‐dependent diabetes mellitusIslet transplantationLong‐term outcome |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Toshihiro Nakamura Junji Fujikura Takayuki Anazawa Ryo Ito Masahito Ogura Hideaki Okajima Shinji Uemoto Nobuya Inagaki |
spellingShingle |
Toshihiro Nakamura Junji Fujikura Takayuki Anazawa Ryo Ito Masahito Ogura Hideaki Okajima Shinji Uemoto Nobuya Inagaki Long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: An observational cohort study Journal of Diabetes Investigation Insulin‐dependent diabetes mellitus Islet transplantation Long‐term outcome |
author_facet |
Toshihiro Nakamura Junji Fujikura Takayuki Anazawa Ryo Ito Masahito Ogura Hideaki Okajima Shinji Uemoto Nobuya Inagaki |
author_sort |
Toshihiro Nakamura |
title |
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_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_sort |
long‐term outcome of islet transplantation on insulin‐dependent diabetes mellitus: an observational cohort study |
publisher |
Wiley |
series |
Journal of Diabetes Investigation |
issn |
2040-1116 2040-1124 |
publishDate |
2020-03-01 |
description |
Abstract 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. |
topic |
Insulin‐dependent diabetes mellitus Islet transplantation Long‐term outcome |
url |
https://doi.org/10.1111/jdi.13128 |
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