title: A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control.
abstract: 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).
  
  
  
  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.
  
  
  
  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/m2and 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).
  
  
  
  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).
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Junko
authors.initials: J
authors.lastname: Sato
authors.affiliation: 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.
authors.forename: Akio
authors.initials: A
authors.lastname: Kanazawa
authors.affiliation: Department of Nutrition, Juntendo University Hospital, Japan.
authors.forename: Sumiko
authors.initials: S
authors.lastname: Makita
authors.affiliation: Department of Nutrition, Juntendo University Hospital, Japan.
authors.forename: Chie
authors.initials: C
authors.lastname: Hatae
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Komiya
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Shimizu
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Fuki
authors.initials: F
authors.lastname: Ikeda
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Tamura
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ogihara
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Mita
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Goto
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Toyoyoshi
authors.initials: T
authors.lastname: Uchida
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Miyatsuka
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Kageumi
authors.initials: K
authors.lastname: Takeno
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Shimada
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Chie
authors.initials: C
authors.lastname: Ohmura
authors.affiliation: Department of Nutrition, Juntendo University Hospital, Japan.
authors.forename: Takehito
authors.initials: T
authors.lastname: Watanabe
authors.affiliation: Department of Nutrition, Juntendo University Hospital, Japan.
authors.forename: Kiyoe
authors.initials: K
authors.lastname: Kobayashi
authors.affiliation: Department of Nutrition, Juntendo University Hospital, Japan.
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Miura
authors.affiliation: Department of Nutrition, Juntendo University Hospital, Japan.
authors.forename: Manami
authors.initials: M
authors.lastname: Iwaoka
authors.affiliation: Department of Nutrition, Juntendo University Hospital, Japan.
authors.forename: Nao
authors.initials: N
authors.lastname: Hirashima
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Molecular Diabetology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Fujitani
authors.affiliation: 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.
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Watada
mesh_terms: D000368:Aged; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000178:diet therapy* / Q000208:ethnology; D050528:Diet, Carbohydrate-Restricted / Q000208:ethnology; D003927:Diet, Diabetic / Q000208:ethnology; D004038:Diet, Reducing / Q000208:ethnology; D002149:Energy Intake / Q000208:ethnology; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000517:prevention & control*; D007564:Japan; D008297:Male; D008875:Middle Aged; D052756:Nutritional Sciences / Q000193:education; D050177:Overweight / Q000097:blood / Q000150:complications / Q000178:diet therapy / Q000208:ethnology; D010349:Patient Compliance / Q000208:ethnology; D010353:Patient Education as Topic; D057285:Precision Medicine; D015431:Weight Loss / Q000208:ethnology
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Calorie-restricted diet; Low-carbohydrate diet; Type 2 diabetes