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. 2014 Apr 23;2(1):e000003.
doi: 10.1136/bmjdrc-2013-000003. eCollection 2014.

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

Naoki Sakane  1 , Juichi Sato  2 , Kazuyo Tsushita  3 , Satoru Tsujii  4 , Kazuhiko Kotani  5 , Makoto Tominaga  6 , Shoji Kawazu  7 , Yuzo Sato  8 , Takeshi Usui  9 , Isao Kamae  10 , Toshihide Yoshida  11 , Yutaka Kiyohara  12 , Shigeaki Sato  13 , Kokoro Tsuzaki  1 , Kaoru Takahashi  14 , Hideshi Kuzuya  15 ; Japan Diabetes Prevention Program (JDPP) Research Group
Affiliations

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

Naoki Sakane et al. BMJ Open Diabetes Res Care. .

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.

Keywords: HbA1c; Impaired Glucose Tolerance; Intervention Groups; Type 2 Diabetes.

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Figures

Figure 1
Figure 1
CONSORT flow diagram of Japan Diabetes Prevention Program (JDPP). DM, diabetes mellitus; HbA1c, glycated hemoglobin; IFG, impaired fasting glucose; NGT, normal glucose tolerance.
Figure 2
Figure 2
Kaplan-Meier plot of development of diabetes according to glycated hemoglobin (HbA1c) categories.
See this image and copyright information in PMC

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