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A randomized controlled trial of a structured program combining aerobic and resistance exercise for adults with type 2 diabetes in Japan

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Abstract

Background

We assessed the effect of supervised, combined aerobic and resistance exercise on diabetic parameters in Japanese patients with type 2 diabetes mellitus (T2DM).

Methods

This 12-week, multicenter (17 medical institutions), open-label, parallel-group study (clinicaltrials.jp; JapicCTI-184002), randomized (1:1) Japanese patients aged 20–75 years with T2DM and hemoglobin A1c (HbA1c) of 7.0–10.0% to supervised exercise (n = 113) or standard therapy (n = 115). The supervised exercise group undertook supervised aerobic (30 min) and resistance exercise 3 times/week (20 designated gyms). Primary endpoint was change in HbA1c from baseline at week 13. Secondary endpoints were change in fasting blood glucose (FBG), glycoalbumin, fasting insulin, homeostatic model assessment of insulin resistance (HOMA-IR), and HOMA-β at week 13.

Results

Of 228 randomized patients, 97 (85.8%) in the supervised exercise group and 108 (93.9%) in the standard therapy group completed the study. Supervised exercise significantly lowered HbA1c at week 13 versus standard therapy (estimated difference in change from baseline [95% confidence interval]: − 0.44% [− 0.61, − 0.28], p < 0.001). Supervised exercise also significantly decreased FBG (estimated difference: − 13.0 [− 19.2, − 6.7] mg/dL) and glycoalbumin (estimated difference:  − 1.52% [− 2.10, − 0.93]) compared with standard therapy. Fasting insulin (− 0.5 µIU/mL) and HOMA-IR (− 0.3) decreased with supervised exercise, but group differences were not significant. Treatment-emergent adverse events were more frequent in the supervised exercise group (42.5%) than in the standard therapy group (29.6%); however, no major safety concerns were identified.

Conclusions

A structured, supervised, aerobic and resistance exercise program improved HbA1c and was well accepted among patients with T2DM.

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Data accessibility and materials

Researchers may request access to anonymized participant level data, trial level data, and protocols from Astellas-sponsored clinical trials at www.clinicalstudydatarequest.com. For the Astellas criteria on data sharing, see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx.

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Acknowledgements

The authors would like to thank all study participants, medical staff, and exercise trainers. We also acknowledge the contribution of Motohiro Kanayama (Astellas Pharma Inc.) in the design of the exercise program and assistance with conducting the trial.

This study was funded by Astellas Pharma Inc. Medical writing assistance was provided by Rebecca Lew, PhD, CMPP, and Joanna Best, PhD, of ProScribe-Envision Pharma Group, funded by Astellas Pharma Inc. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).

Funding

Astellas Pharma Inc. was involved in the study design, data collection, data analysis, and preparation of the manuscript.

Author information

Authors and Affiliations

  1. Department of Endocrinology and Metabolism, Yokohama City University, Yokohama, Japan

    Yasuo Terauchi

  2. Clinical Operation and Innovation Group–Japan/Asia Clinical Development Department 2, Astellas Pharma Inc, 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan

    Tetsushi Takada

  3. Data Science Department, Development Division, Astellas Pharma Inc, Tokyo, Japan

    Satoshi Yoshida

Authors
  1. Yasuo Terauchi
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  3. Satoshi Yoshida
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Contributions

All authors participated in the study design, analysis, and interpretation of study results, and in the drafting, critical revision, and approval of the final version of the manuscript. Tetsushi Takada collected the data. All authors agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Tetsushi Takada.

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Conflicts of interest

Yasuo Terauchi has received lecture fees from Astellas Pharma Inc., AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd., Eli Lilly Japan K.K., Merck Sharp & Dohme K.K., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Sanwa Kagaku Kenkyusho Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Co., Ltd., and has received research donations from AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd., Eli Lilly Japan K.K., Merck Sharp & Dohme K.K., Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., and Takeda Pharmaceutical Co., Ltd. Tetsushi Takada is an employee of Astellas Pharma Inc. Satoshi Yoshida is an employee of Astellas Pharma Inc.

Ethical standards

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and/or with the Helsinki Declaration of 1964 and later versions. Informed consent was obtained from all patients for being included in the study.

Human rights statement

This research involves human participants. The study protocol was approved by the local ethics committee at each medical institution, the Medical Corporation Toukeikai Kitamachi Clinic Ethical Review Board (approval number AST05921, approved June 28, 2018), or the Joint Ethical Review Board (approval number 14000050.20180817-4654, approved August 17, 2018).

Informed consent

All patients provided written informed consent before participating.

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Terauchi, Y., Takada, T. & Yoshida, S. A randomized controlled trial of a structured program combining aerobic and resistance exercise for adults with type 2 diabetes in Japan. Diabetol Int 13, 75–84 (2022). https://doi.org/10.1007/s13340-021-00506-5

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  • DOI: https://doi.org/10.1007/s13340-021-00506-5

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