title: Design of and rationale for the Japan Diabetes Optimal Integrated Treatment study for 3 major risk factors of cardiovascular diseases (J-DOIT3): a multicenter, open-label, randomized, parallel-group trial.
abstract: OBJECTIVE
  Multifactorial intervention including the management of levels of blood glucose (BG), blood pressure (BP), and lipids has been suggested to decrease cardiovascular disease (CVD) risk. However, the target ideal and feasible levels for these individual parameters have not been fully evaluated. In this study, we examine the hypothesis that stricter control compared with the current targets in the Japanese guideline for BG, BP, and lipids could efficiently and safely reduce CVD risk.
  
  
  METHODS
  We screened patients with type 2 diabetes and hypertension and/or dyslipidemia among 81 hospitals in Japan and allocated them into 2 groups: the intensive therapy group (ITG) and the conventional therapy group (CTG). For the 2 respective groups, the target for glycated hemoglobin (HbA1c) is <6.2% (44 mmol/mol) and <6.9% (52 mmol/mol), for BP it is <120/75 mm Hg and <130/80 mm Hg, and for low-density lipoprotein cholesterol it is <80 mg/dL (<70 mg/dL in the presence of CVD history) and <120 mg/dL (<100 mg/dL in the presence of CVD history). The primary end point is the occurrence of CVD events or death by any cause. These patients are scheduled for stepwise intensifications of medication for BG, BP, and lipid control in the ITG, until the number of primary end point events reaches 250.
  
  
  RESULTS
  We recruited 2542 patients and randomly allocated 1271 into the ITG and 1271 into the CTG between June 2006 and March 2009. The mean HbA1c was 8.0% (64 mmol/mol) and the mean duration of diabetes was 8.3 years.
  
  
  CONCLUSIONS
  This randomized controlled study will test the hypothesis that strict multifactorial intervention therapy is effective for the prevention of CVDs in patients with type 2 diabetes who are at high CVD risk.
  
  
  BACKGROUND
  NCT00300976.
authors: Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Molecular Sciences on Diabetes, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Molecular Diabetic Medicine, Diabetes Research Center, National Center for Global Health and Medicine, Tokyo, Japan; Translational Systems Biology and Medicine Initiative (TSBMI), The University of Tokyo, Tokyo, Japan.
authors: Kohjiro
authors: K
authors: Ueki
authors: Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Molecular Diabetic Medicine, Diabetes Research Center, National Center for Global Health and Medicine, Tokyo, Japan; Translational Systems Biology and Medicine Initiative (TSBMI), The University of Tokyo, Tokyo, Japan.
authors: Takayoshi
authors: T
authors: Sasako
authors: Fiore Kenshin Clinic , Tokyo , Japan.
authors: Masayuki
authors: M
authors: Kato
authors: Department of Diabetes and Metabolic Diseases , Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.
authors: Yukiko
authors: Y
authors: Okazaki
authors: Division of Diabetes and Metabolism , Toho University Ohashi Medical Center , Tokyo , Japan.
authors: Sumie
authors: S
authors: Okahata
authors: Department of Internal Medicine , National Center for Global Health and Medicine, Kohnodai Hospital , Chiba , Japan.
authors: Hisayuki
authors: H
authors: Katsuyama
authors: Department of Diabetes and Metabolic Diseases , Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.
authors: Mikiko
authors: M
authors: Haraguchi
authors: Department of Diabetes and Metabolic Diseases , Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.
authors: Ai
authors: A
authors: Morita
authors: Department of General Internal Medicine , National Cancer Center Hospital , Tokyo , Japan.
authors: Ken
authors: K
authors: Ohashi
authors: Department of Diabetes, Endocrinology and Metabolism , Tokyo Medical University , Tokyo , Japan.
authors: Kazuo
authors: K
authors: Hara
authors: Department of Endocrinology and Metabolism , Toranomon Hospital , Tokyo , Japan.
authors: Atsushi
authors: A
authors: Morise
authors: Division of Rare/Intractable Disease Research, Department of Research Promotion , Japan Agency for Medical Research and Development , Tokyo , Japan.
authors: Kazuo
authors: K
authors: Izumi
authors: Department of Integrated Science and Engineering for Sustainable Society , Chuo University , Tokyo , Japan.
authors: Yasuo
authors: Y
authors: Ohashi
authors: Department of Diabetes Research , National Center for Global Health and Medicine , Tokyo , Japan.
authors: Mitsuhiko
authors: M
authors: Noda
authors: Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Translational Systems Biology and Medicine Initiative (TSBMI), The University of Tokyo, Tokyo, Japan.
authors: Takashi
authors: T
authors: Kadowaki
keywords: Intensified Therapy; Lifestyle Modification; Multifactorial Interventions; Weight Control