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 - PubMed (original) (raw)

. 2014 Apr 23;2(1):e000003.

doi: 10.1136/bmjdrc-2013-000003. eCollection 2014.

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. 2014.

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.

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