ROSIGLITAZONE VS PLACEBO: EFFECT OF CV PERFORMANCE AND MYOCARDIAL TRIGLYCERIDE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的主要目的是确定6个月的罗格列酮治疗（一种通常用于治疗2型糖尿病高血糖的噻唑类药物）与安慰剂相比，心血管疾病或有额外心血管危险因素的患者是否能改善心血管综合表现，通过运动跑步机测试时的峰值摄氧量来评估；2) MRI对心脏结构和功能的影响；3)利用核磁共振技术降低心肌细胞内（异位）甘油三酯沉积，以及心肌内脂质含量的变化与心脏结构和功能的变化之间的关系。这项多中心随机安慰剂对照双盲平行组研究将使用德克萨斯大学西南分校多纳尔·w·雷诺兹心血管临床研究中心开发的临床研究基础设施和资源，以及其他三家雷诺兹中心——斯坦福大学、布里格姆妇女医院和约翰·霍普金斯大学的合作参与。基于UT西南雷诺兹中心和GCRC在达拉斯心脏研究（SPID 0645）中建立的合作先例，GCRC的资源将再次用于核心实验室，偶尔只用于UT西南的门诊资源。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objectives of this study are to determine if 6 months of treatment with rosiglitazone, a thiazolidmedione medication commonly used in the treatment of hyperglycemia of type 2 diabetes, versus placebo in patients with cardiovascular disease or with an additional cardiovascular risk factor 1) improves integrated cardiovascular performance, assessed by peak oxygen uptake during exercise treadmill testing; 2) effects cardiac structure and function as assess by MRI; and 3) decreases intracellular (ectopic) triglyceride deposition in cardiomyocytes using nuclear magnetic resonance techniques, and how changes in intra-myocardial lipid content relate to changes in cardiac structure and function. This multi-center randomized placebo-controlled double-blinded parallel group study will use the clinical research infrastructure and resources developed in the Donal W. Reynolds Cardiovascular Clinical Research Center at UT Southwestern, and the collaborative participation of the other 3 Reynolds Centers - Stanford, Brigham and Women's Hospital, and Johns Hopkins. Based on the precedent of collaboration established between the UT Southwestern Reynolds Center and the GCRC in the Dallas Heart Study (SPID 0645), GCRC resources will again be utilized for Core Lab and occasional outpatient resources only at UT Southwestern.