title: Effects of sitagliptin on coronary atherosclerosis evaluated using integrated backscatter intravascular ultrasound in patients with type 2 diabetes: rationale and design of the TRUST study.
abstract: Patients with diabetes mellitus are at high risk for developing coronary artery disease (CAD), even if they are treated with statins. Several studies have shown the beneficial effects of dipeptidyl peptidase-4 (DPP-4) inhibitors on the cardiovascular system in an animal model. However, recent clinical trials using DPP-4 inhibitors have shown that these inhibitors fail to reduce the occurrence of cardiovascular events. Therefore, this study will be performed to evaluate the effects of sitagliptin, a DPP-4 inhibitor, on coronary atherosclerosis in patients with type 2 diabetes. This study will be a prospective, open-label, randomized multicenter trial performed in 6 centers in Japan. Stable CAD patients with type 2 diabetes who have undergone successful percutaneous coronary intervention under integrated backscatter (IB)-intravascular ultrasound (IVUS) guidance will be studied. They will be randomly assigned to either the sitagliptin group or a control group. After 48 weeks' treatment, the IVUS examination will be repeated in the same coronary artery as at baseline. The primary end point will be the percentage change in plaque volume measured using grayscale IVUS from baseline to the 48-week follow-up. This study will be the first multicenter trial to evaluate the effects of a DPP-4 inhibitor on coronary atherosclerosis evaluated using IB-IVUS, and the findings will clarify the anti-atherogenic effects of sitagliptin.
authors: Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations, 132 Katsura-cho, Sakae-ku, Yokohama, 247-8581, Japan. nozue2493@yahoo.co.jp.
authors: Tsuyoshi
authors: T
authors: Nozue
authors: Department of Cardiology, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
authors: Kazuki
authors: K
authors: Fukui
authors: Cardiovascular Center, Synthesis Shinkawahashi Hospital, Kawasaki, Japan.
authors: Yutaka
authors: Y
authors: Koyama
authors: Department of Cardiology, Yokohama Minami Kyosai Hospital, Yokohama, Japan.
authors: Hiroyuki
authors: H
authors: Fujii
authors: Fourth Department of Internal Medicine, Mizonokuchi Hospital, Teikyo University School of Medicine, Kawasaki, Japan.
authors: Tomoyuki
authors: T
authors: Kunishima
authors: Cardiovascular Center, Yokosuka Kyosai Hospital, Yokosuka, Japan.
authors: Hiroyuki
authors: H
authors: Hikita
authors: Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.
authors: Kiyoshi
authors: K
authors: Hibi
authors: Cardiocore Japan, Tokyo, Japan.
authors: Akiyoshi
authors: A
authors: Miyazawa
authors: Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations, 132 Katsura-cho, Sakae-ku, Yokohama, 247-8581, Japan.
authors: Ichiro
authors: I
authors: Michishita
mesh_terms: D002985:Clinical Protocols; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D006801:Humans; D054795:Incretins / Q000627:therapeutic use*; D007564:Japan; D062645:Percutaneous Coronary Intervention; D058226:Plaque, Atherosclerotic; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012107:Research Design; D000068900:Sitagliptin Phosphate / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D054795:Incretins; D000068900:Sitagliptin Phosphate
keywords: Coronary atherosclerosis; Diabetes mellitus; Dipeptidyl peptidase-4 inhibitor; Intravascular ultrasound; Sitagliptin