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Clinical care/education/nutrition/psychosocial research
Effect of baseline HbA1c level on the development of diabetes by lifestyle intervention in primary healthcare settings: insights from subanalysis of the Japan Diabetes Prevention Program
  1. Naoki Sakane1,
  2. Juichi Sato2,
  3. Kazuyo Tsushita3,
  4. Satoru Tsujii4,
  5. Kazuhiko Kotani1,5,
  6. Makoto Tominaga6,
  7. Shoji Kawazu7,
  8. Yuzo Sato8,
  9. Takeshi Usui9,
  10. Isao Kamae10,
  11. Toshihide Yoshida11,
  12. Yutaka Kiyohara12,
  13. Shigeaki Sato13,
  14. Kokoro Tsuzaki1,
  15. Kaoru Takahashi1,14,
  16. Hideshi Kuzuya15,16,
  17. the Japan Diabetes Prevention Program (JDPP) Research Group
  1. 1Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
  2. 2Department of General Medicine/Family & Community Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan
  3. 3Comprehensive Health Science Center, Aichi Health Promotion Foundation, Higashiura-cho, Aichi, Japan
  4. 4Diabetes Center, Tenri Yorozu-sodansho Hospital, Tenri, Japan
  5. 5Department of Clinical Laboratory Medicine, Jichi Medical School, Tochigi, Japan
  6. 6Division of Internal Medicine, Hananoki Hospital, Tochigi, Japan
  7. 7Department of Diabetes and Metabolism, Marunouchi Hospital, The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan
  8. 8The Graduate Center of Human Sciences, Aichi Mizuho College, Nagoya, Japan
  9. 9Division of Endocrinology, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
  10. 10Graduate School of Public Policy, The University of Tokyo, Tokyo, Japan
  11. 11Obesity and Diabetes Center, Shimabara Hospital, Kyoto, Japan
  12. 12Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan
  13. 13Hirakata General Hospital for Developmental Disorders, Hirakata, Osaka, Japan
  14. 14Hyogo Health Service Association, Hyogo, Japan
  15. 15National Hospital Organization Kyoto Medical Center, Kyoto, Japan
  16. 16Takeda Hospital, Kyoto, Japan
  1. Correspondence to Dr Naoki Sakane; nsakane{at}kyotolan.hosp.go.jp

Abstract

Objectives To determine the effects of a lifestyle intervention on the development of type 2 diabetes mellitus (T2DM) among participants with impaired glucose tolerance (IGT), in particular in the subgroup with baseline glycated hemoglobin (HbA1c) levels ≥5.7%, in primary healthcare settings.

Design Randomized controlled trial.

Setting 32 healthcare centers in Japan.

Participants Participants with IGT, aged 30–60 years, were randomly assigned to either an intensive lifestyle intervention group (ILG) or a usual care group (UCG).

Interventions During the initial 6 months, participants in the ILG received four group sessions on healthy lifestyles by public health providers. An individual session was further conducted biannually during the 3 years. Participants in the UCG received usual care such as one group session on healthy lifestyles.

Outcome measures The primary endpoint was the development of T2DM based on an oral glucose tolerance test.

Results The mean follow-up period was 2.3 years. The annual incidence of T2DM were 2.7 and 5.1/100 person-years of follow-up in the ILG (n=145) and UCG (n=149), respectively. The cumulative incidence of T2DM was significantly lower in the ILG than in the UCG among participants with HbA1c levels ≥5.7% (log-rank=3.52, p=0.06; Breslow=4.05, p=0.04; Tarone-Ware=3.79, p=0.05), while this was not found among participants with HbA1c levels <5.7%.

Conclusions Intensive lifestyle intervention in primary healthcare setting is effective in preventing the development of T2DM in IGT participants with HbA1c levels ≥5.7%, relative to those with HbA1c levels <5.7%.

Trial registration number UMIN000003136.

  • HbA1c
  • Type 2 Diabetes
  • Impaired Glucose Tolerance
  • Intervention Groups

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/bmjdrc-2013-000003

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