title: Randomized comparison of the effects of rosiglitazone vs. placebo on peak integrated cardiovascular performance, cardiac structure, and function.
abstract: OBJECTIVE
  To assess the effect of rosiglitazone on cardiovascular performance and cardiac function.
  
  
  RESULTS
  One hundred and fifty type 2 diabetes patients with cardiovascular disease (CVD) or ≥ 1 other CVD risk factor were randomized to receive rosiglitazone vs. placebo for 6 months. The primary outcome was peak oxygen uptake indexed to fat-free mass (VO(2peak)-FFM) during maximum exercise. A subset of 102 subjects underwent cardiac magnetic resonance imaging (cMRI). On hundred and eight subjects completed the study, including 75 completing the cMRI substudy. No significant differences were observed in mean VO(2peak)-FFM between rosiglitazone and placebo (26.1 ± 7.0 vs. 27.6 ± 6.6 mL/kg-FFM/min; P = 0.26). Compared with placebo, the rosiglitazone group had lower hematocrit (38 vs. 41%; P < 0.001) and more peripheral oedema (53.7 vs. 33.3%; P = 0.03). In the cMRI substudy, compared with placebo, the rosiglitazone group had larger end-diastolic volume (128.1 vs. 112.0 mL; P = 0.01) and stroke volume (83.7 vs. 72.9 mL; P = 0.01), and a trend toward increased peak ventricular filling rate (79.4 vs. 60.5; P = 0.07).
  
  
  CONCLUSIONS
  Rosiglitazone increased peripheral oedema but had no pernicious effects on cardiovascular performance or cardiac function, with modest improvement in selected cMRI measures. Changes in indirect markers of plasma volume suggest expansion with rosiglitazone.
  
  
  BACKGROUND
  clinicaltrials.gov identifier: NCT00424762.
authors.affiliation: Cardiovascular Division, University of Texas Southwestern Medical Center, 5909 Harry Hines Blvd, Room HA9.133, Dallas, TX 75235-9047, USA. darren.mcguire@utsouthwestern.edu
authors.forename: Darren K
authors.initials: DK
authors.lastname: McGuire
authors.forename: Shuaib M
authors.initials: SM
authors.lastname: Abdullah
authors.forename: Raphael
authors.initials: R
authors.lastname: See
authors.forename: Peter G
authors.initials: PG
authors.lastname: Snell
authors.forename: Jonathan
authors.initials: J
authors.lastname: McGavock
authors.forename: Lidia S
authors.initials: LS
authors.lastname: Szczepaniak
authors.forename: Colby R
authors.initials: CR
authors.lastname: Ayers
authors.forename: Mark H
authors.initials: MH
authors.lastname: Drazner
authors.forename: Amit
authors.initials: A
authors.lastname: Khera
authors.forename: James A
authors.initials: JA
authors.lastname: de Lemos
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology; D003925:Diabetic Angiopathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D010101:Oxygen Consumption / Q000187:drug effects / Q000502:physiology; D010953:Plasma Volume / Q000187:drug effects; D000077154:Rosiglitazone; D013318:Stroke Volume / Q000502:physiology; D045162:Thiazolidinediones / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone