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α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study

BACKGROUND: Little is known about clinical associations between glucose fluctuations including hypoglycemia, heart rate variability (HRV), and the activity of the sympathetic nervous system (SNS) in patients with acute phase of acute coronary syndrome (ACS). This pilot study aimed to evaluate the sh...

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Autores principales: Shimabukuro, Michio, Tanaka, Atsushi, Sata, Masataka, Dai, Kazuoki, Shibata, Yoshisato, Inoue, Yohei, Ikenaga, Hiroki, Kishimoto, Shinji, Ogasawara, Kozue, Takashima, Akira, Niki, Toshiyuki, Arasaki, Osamu, Oshiro, Koichi, Mori, Yutaka, Ishihara, Masaharu, Node, Koichi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501494/
https://www.ncbi.nlm.nih.gov/pubmed/28683829
http://dx.doi.org/10.1186/s12933-017-0571-1
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author Shimabukuro, Michio
Tanaka, Atsushi
Sata, Masataka
Dai, Kazuoki
Shibata, Yoshisato
Inoue, Yohei
Ikenaga, Hiroki
Kishimoto, Shinji
Ogasawara, Kozue
Takashima, Akira
Niki, Toshiyuki
Arasaki, Osamu
Oshiro, Koichi
Mori, Yutaka
Ishihara, Masaharu
Node, Koichi
author_facet Shimabukuro, Michio
Tanaka, Atsushi
Sata, Masataka
Dai, Kazuoki
Shibata, Yoshisato
Inoue, Yohei
Ikenaga, Hiroki
Kishimoto, Shinji
Ogasawara, Kozue
Takashima, Akira
Niki, Toshiyuki
Arasaki, Osamu
Oshiro, Koichi
Mori, Yutaka
Ishihara, Masaharu
Node, Koichi
author_sort Shimabukuro, Michio
collection PubMed
description BACKGROUND: Little is known about clinical associations between glucose fluctuations including hypoglycemia, heart rate variability (HRV), and the activity of the sympathetic nervous system (SNS) in patients with acute phase of acute coronary syndrome (ACS). This pilot study aimed to evaluate the short-term effects of glucose fluctuations on HRV and SNS activity in type 2 diabetes mellitus (T2DM) patients with recent ACS. We also examined the effect of suppressing glucose fluctuations with miglitol on these variables. METHODS: This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group comparative study included 39 T2DM patients with recent ACS, who were randomly assigned to either a miglitol group (n = 19) or a control group (n = 20). After initial 24-h Holter electrocardiogram (ECG) (Day 1), miglitol was commenced and another 24-h Holter ECG (Day 2) was recorded. In addition, continuous glucose monitoring (CGM) was performed throughout the Holter ECG. RESULTS: Although frequent episodes of subclinical hypoglycemia (≤4.44 mmo/L) during CGM were observed on Day 1 in the both groups (35% of patients in the control group and 31% in the miglitol group), glucose fluctuations were decreased and the minimum glucose level was increased with substantial reduction in the episodes of subclinical hypoglycemia to 7.7% in the miglitol group on Day 2. Holter ECG showed that the mean and maximum heart rate and mean LF/HF were increased on Day 2 in the control group, and these increases were attenuated by miglitol. When divided 24-h time periods into day-time (0700–1800 h), night-time (1800–0000 h), and bed-time (0000–0700 h), we found increased SNS activity during day-time, increased maximum heart rate during night-time, and glucose fluctuations during bed-time, which were attenuated by miglitol treatment. CONCLUSIONS: In T2DM patients with recent ACS, glucose fluctuations with subclinical hypoglycemia were associated with alterations of HRV and SNS activity, which were mitigated by miglitol, suggesting that these pathological relationships may be a residual therapeutic target in such patients. Trial registration Unique Trial Number, UMIN000005874 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006929) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12933-017-0571-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-55014942017-07-10 α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study Shimabukuro, Michio Tanaka, Atsushi Sata, Masataka Dai, Kazuoki Shibata, Yoshisato Inoue, Yohei Ikenaga, Hiroki Kishimoto, Shinji Ogasawara, Kozue Takashima, Akira Niki, Toshiyuki Arasaki, Osamu Oshiro, Koichi Mori, Yutaka Ishihara, Masaharu Node, Koichi Cardiovasc Diabetol Original Investigation BACKGROUND: Little is known about clinical associations between glucose fluctuations including hypoglycemia, heart rate variability (HRV), and the activity of the sympathetic nervous system (SNS) in patients with acute phase of acute coronary syndrome (ACS). This pilot study aimed to evaluate the short-term effects of glucose fluctuations on HRV and SNS activity in type 2 diabetes mellitus (T2DM) patients with recent ACS. We also examined the effect of suppressing glucose fluctuations with miglitol on these variables. METHODS: This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group comparative study included 39 T2DM patients with recent ACS, who were randomly assigned to either a miglitol group (n = 19) or a control group (n = 20). After initial 24-h Holter electrocardiogram (ECG) (Day 1), miglitol was commenced and another 24-h Holter ECG (Day 2) was recorded. In addition, continuous glucose monitoring (CGM) was performed throughout the Holter ECG. RESULTS: Although frequent episodes of subclinical hypoglycemia (≤4.44 mmo/L) during CGM were observed on Day 1 in the both groups (35% of patients in the control group and 31% in the miglitol group), glucose fluctuations were decreased and the minimum glucose level was increased with substantial reduction in the episodes of subclinical hypoglycemia to 7.7% in the miglitol group on Day 2. Holter ECG showed that the mean and maximum heart rate and mean LF/HF were increased on Day 2 in the control group, and these increases were attenuated by miglitol. When divided 24-h time periods into day-time (0700–1800 h), night-time (1800–0000 h), and bed-time (0000–0700 h), we found increased SNS activity during day-time, increased maximum heart rate during night-time, and glucose fluctuations during bed-time, which were attenuated by miglitol treatment. CONCLUSIONS: In T2DM patients with recent ACS, glucose fluctuations with subclinical hypoglycemia were associated with alterations of HRV and SNS activity, which were mitigated by miglitol, suggesting that these pathological relationships may be a residual therapeutic target in such patients. Trial registration Unique Trial Number, UMIN000005874 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006929) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12933-017-0571-1) contains supplementary material, which is available to authorized users. BioMed Central 2017-07-06 /pmc/articles/PMC5501494/ /pubmed/28683829 http://dx.doi.org/10.1186/s12933-017-0571-1 Text en © The Author(s) 2017 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 Original Investigation
Shimabukuro, Michio
Tanaka, Atsushi
Sata, Masataka
Dai, Kazuoki
Shibata, Yoshisato
Inoue, Yohei
Ikenaga, Hiroki
Kishimoto, Shinji
Ogasawara, Kozue
Takashima, Akira
Niki, Toshiyuki
Arasaki, Osamu
Oshiro, Koichi
Mori, Yutaka
Ishihara, Masaharu
Node, Koichi
α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study
title α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study
title_full α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study
title_fullStr α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study
title_full_unstemmed α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study
title_short α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (MACS) study
title_sort α-glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized controlled (macs) study
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501494/
https://www.ncbi.nlm.nih.gov/pubmed/28683829
http://dx.doi.org/10.1186/s12933-017-0571-1
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