title: Effects of alogliptin on fractional flow reserve evaluated by coronary computed tomography angiography in patients with type 2 diabetes: Rationale and design of the TRACT study.
abstract: Patients with type 2 diabetes are at high risk for developing coronary artery disease (CAD). Noninvasive anatomic assessment by coronary computed tomography angiography (CCTA) is being increasingly used for detecting or excluding CAD. Recently, fractional flow reserve (FFR) using routinely acquired CCTA datasets (FFRCT) has been developed. Although intensive glycemic control can reduce the risk of microvascular complications, intensive glucose control does not seem to be beneficial in preventing major cardiovascular events when compared with standard therapy. However, it has been reported that dipeptidyl peptidase-4 (DPP-4) inhibitors have anti-atherogenic effects in an animal model. In addition, DPP-4 inhibitors attenuate the progression of carotid intima-media thickness in patients with type 2 diabetes. Therefore, this study will be performed to evaluate the effects of alogliptin, a DPP-4 inhibitor, on coronary atherosclerosis using FFRCTin patients with type 2 diabetes.
  
  
  
  This study will be a prospective, non-randomized, multicenter trial performed in Japan. Patients with type 2 diabetes who have intermediate coronary artery stenosis (diameter stenosis <70%) as evaluated by CCTA will be treated with 25mg/day of alogliptin. After 48 weeks' treatment, CCTA will be repeated. The primary endpoint will be changes in FFRCT, and the secondary endpoint will be the change in plaque volume from baseline to the 48-week follow-up.
  
  
  
  This study will be the first multicenter trial to evaluate the effects of alogliptin on coronary atherosclerosis using the newly developed FFRCTas the primary endpoint, and the findings will clarify the anti-atherogenic effects of alogliptin.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Yokohama, Japan. Electronic address: nozue2493@yahoo.co.jp.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Nozue
authors.affiliation: Department of Cardiology, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
authors.forename: Kazuki
authors.initials: K
authors.lastname: Fukui
authors.affiliation: Department of Cardiology, Nagatsuda Kosei General Hospital, Yokohama, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Takamura
authors.affiliation: Department of Biostatistics, Kyoto University School of Public Health, Kyoto, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sozu
authors.affiliation: Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Hibi
authors.affiliation: Cardiocore Japan, Tokyo, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Kishi
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Yokohama, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Michishita
mesh_terms: D000368:Aged; D059168:Carotid Intima-Media Thickness; D000072226:Computed Tomography Angiography; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000188:drug therapy* / Q000503:physiopathology*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000000981:diagnostic imaging; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D005260:Female; D053805:Fractional Flow Reserve, Myocardial / Q000187:drug effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D058226:Plaque, Atherosclerotic / Q000188:drug therapy; D011446:Prospective Studies; D014498:Uracil / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D007004:Hypoglycemic Agents; D010880:Piperidines; D014498:Uracil; C520853:alogliptin
keywords: Alogliptin; Coronary atherosclerosis; Coronary computed tomography angiography; Dipeptidyl peptidase-4 inhibitor; Fractional flow reserve