PMID- 27472929 OWN - NLM STAT- MEDLINE DCOM- 20180326 LR - 20221207 IS - 1532-1983 (Electronic) IS - 0261-5614 (Linking) VI - 36 IP - 4 DP - 2017 Aug TI - A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control. PG - 992-1000 LID - S0261-5614(16)30169-8 [pii] LID - 10.1016/j.clnu.2016.07.003 [doi] AB - 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 (28x 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/m(2) 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/m(2)] 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). CI - Copyright (c) 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. FAU - Sato, Junko AU - Sato J AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Kanazawa, Akio AU - Kanazawa A AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Therapeutic Innovations in Diabetes, Juntendo University Graduate School of Medicine, Tokyo, Japan. Electronic address: akana@juntendo.ac.jp. FAU - Makita, Sumiko AU - Makita S AD - Department of Nutrition, Juntendo University Hospital, Japan. FAU - Hatae, Chie AU - Hatae C AD - Department of Nutrition, Juntendo University Hospital, Japan. FAU - Komiya, Koji AU - Komiya K AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Shimizu, Tomoaki AU - Shimizu T AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Ikeda, Fuki AU - Ikeda F AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Tamura, Yoshifumi AU - Tamura Y AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Ogihara, Takeshi AU - Ogihara T AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Mita, Tomoya AU - Mita T AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Goto, Hiromasa AU - Goto H AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Uchida, Toyoyoshi AU - Uchida T AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Miyatsuka, Takeshi AU - Miyatsuka T AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Takeno, Kageumi AU - Takeno K AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Shimada, Satoshi AU - Shimada S AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Ohmura, Chie AU - Ohmura C AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Watanabe, Takehito AU - Watanabe T AD - Department of Nutrition, Juntendo University Hospital, Japan. FAU - Kobayashi, Kiyoe AU - Kobayashi K AD - Department of Nutrition, Juntendo University Hospital, Japan. FAU - Miura, Yoshiko AU - Miura Y AD - Department of Nutrition, Juntendo University Hospital, Japan. FAU - Iwaoka, Manami AU - Iwaoka M AD - Department of Nutrition, Juntendo University Hospital, Japan. FAU - Hirashima, Nao AU - Hirashima N AD - Department of Nutrition, Juntendo University Hospital, Japan. FAU - Fujitani, Yoshio AU - Fujitani Y AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Molecular Diabetology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Watada, Hirotaka AU - Watada H AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Therapeutic Innovations in Diabetes, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Molecular Diabetology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan. LA - eng SI - UMIN CTR/000010663 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20160718 PL - England TA - Clin Nutr JT - Clinical nutrition (Edinburgh, Scotland) JID - 8309603 RN - 0 (Glycated Hemoglobin A) RN - 0 (hemoglobin A1c protein, human) SB - IM MH - Aged MH - Body Mass Index MH - Diabetes Mellitus, Type 2/blood/complications/*diet therapy/ethnology MH - *Diet, Carbohydrate-Restricted/ethnology MH - *Diet, Diabetic/ethnology MH - Diet, Reducing/ethnology MH - Energy Intake/ethnology MH - Female MH - Follow-Up Studies MH - Glycated Hemoglobin/analysis MH - Humans MH - Hyperglycemia/*prevention & control MH - Hypoglycemia/*prevention & control MH - Japan MH - Male MH - Middle Aged MH - Nutritional Sciences/education MH - Overweight/blood/complications/diet therapy/ethnology MH - *Patient Compliance/ethnology MH - Patient Education as Topic MH - *Precision Medicine MH - Weight Loss/ethnology OTO - NOTNLM OT - Calorie-restricted diet OT - Low-carbohydrate diet OT - Type 2 diabetes EDAT- 2016/07/31 06:00 MHDA- 2018/03/27 06:00 CRDT- 2016/07/31 06:00 PHST- 2016/02/17 00:00 [received] PHST- 2016/07/03 00:00 [revised] PHST- 2016/07/12 00:00 [accepted] PHST- 2016/07/31 06:00 [pubmed] PHST- 2018/03/27 06:00 [medline] PHST- 2016/07/31 06:00 [entrez] AID - S0261-5614(16)30169-8 [pii] AID - 10.1016/j.clnu.2016.07.003 [doi] PST - ppublish SO - Clin Nutr. 2017 Aug;36(4):992-1000. doi: 10.1016/j.clnu.2016.07.003. Epub 2016 Jul 18.