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Randomized Controlled Trial
. 2017 Aug;36(4):992-1000.
doi: 10.1016/j.clnu.2016.07.003. Epub 2016 Jul 18.

A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control

Junko Sato  1 , Akio Kanazawa  2 , Sumiko Makita  3 , Chie Hatae  3 , Koji Komiya  1 , Tomoaki Shimizu  1 , Fuki Ikeda  1 , Yoshifumi Tamura  4 , Takeshi Ogihara  1 , Tomoya Mita  1 , Hiromasa Goto  1 , Toyoyoshi Uchida  1 , Takeshi Miyatsuka  1 , Kageumi Takeno  1 , Satoshi Shimada  1 , Chie Ohmura  1 , Takehito Watanabe  3 , Kiyoe Kobayashi  3 , Yoshiko Miura  3 , Manami Iwaoka  3 , Nao Hirashima  3 , Yoshio Fujitani  5 , Hirotaka Watada  6
Affiliations
Randomized Controlled Trial

A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control

Junko Sato et al. Clin Nutr. 2017 Aug.

Abstract

Background & aims: The usefulness of low-carbohydrate diet (LCD) for Japanese patients with type 2 diabetes mellitus (T2DM) has not been fully investigated. Therefore, we compared the effectiveness and safety of LCD with calorie restricted diet (CRD).

Methods: This prospective, randomized, open-label, comparative study included 66 T2DM patients with HbA1c >7.5% even after receiving repeated education programs on CRD. They were randomly allocated to either the 130g/day LCD group (n = 33) or CRD group (n = 33). Patients received personal nutrition education of CRD or LCD for 30 min at baseline, 1, 2, 4, and 6 months. Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients (28× ideal body weight calories per day). Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions. Several parameters were assessed at baseline and 6 months after each intervention. The primary endpoint was a change in HbA1c level from baseline to the end of the study.

Results: At baseline, BMI and HbA1c were 26.5 (24.6-30.1) and 8.3 (8.0-9.3), and 26.7 (25.0-30.0) kg/m2 and 8.0 (7.6-8.9) %, in the CRD and LCD, respectively. At the end of the study, HbA1c decreased by -0.65 (-1.53 to -0.10) % in the LCD group, compared with 0.00 (-0.68 to 0.40) % in the CRD group (p < 0.01). Also, the decrease in BMI in the LCD group [-0.58 (-1.51 to -0.16) kg/m2] exceeded that observed in the CRD group (p = 0.03).

Conclusions: Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with T2DM. LCD is a potentially useful nutrition therapy for Japanese patients who cannot adhere to CRD. This trial was registered at http://www.umin.ac.jp/english/ (University Hospital Medical Information Network: study ID number 000010663).

Keywords: Calorie-restricted diet; Low-carbohydrate diet; Type 2 diabetes.

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