BARIATRIC SURGERY CLINICAL RESEARCH CONSORTIUM

描述(由申请人提供)： 肥胖研究的一个主要目标是确定肥胖的病理生理学，以此作为预防和/或有效治疗该疾病的基础。涉及减肥手术患者的研究领域可能包括：1)确定最佳手术方法，2)确定影响合并症发展和手术结果的生物和遗传差异，以及3)利用这一人群作为研究肥胖发病机制和治疗反应的模型。我们建议减肥研究临床研究联盟(BSCRC)采用一个全面的关系数据库，其中包括所有临床中心(CCS)随时可用的参数，如基本人体测量学、身体成分测量、临床和手术史，以及定量共病分级的记录。该量表对17种与肥胖有关的合并症进行评分，包括糖尿病、高血压和高脂血症，并将治疗作为症状严重程度的衡量标准。BSCRC参与者可能需要对共病等级进行进一步改进。这一量表将使共病与mRNA表达谱和内分泌反应相关联。 加州大学戴维斯分校为BSCRC的行为提出了两个具体的协议。短期方案将使用定量聚合酶链式反应，测量减肥手术患者手术时皮下和大网膜脂肪、肝脏和肠道中肥胖相关基因的mRNA表达水平。身体成分的测量，包括体脂分布、胃旁路手术的内分泌反应和临床合并症评分，将允许对受试者从手术时到术后2年的各个时间点进行详细的表型分析。这将是了解相似肥胖症受试者之间共病发生率差异的重要的第一步。更长期的方案将是一个3-5年的纵向研究，研究胃旁路手术的反应与激素活性、身体成分和体力活动的关系。在这一阶段，与短期研究中得出的术前遗传和内分泌标记物以及共病病史评分的相关性将确定哪些患者将从胃旁路手术中受益最大。BSCRC积累的这些数据和其他数据将为进一步研究肥胖合并疾病及其对手术治疗的反应提供基础。

DESCRIPTION (provided by applicant): A primary objective of obesity research is to define the pathophysiology of obesity as a basis for preventing and/or effectively treating the disease. The areas for research involving bariatric surgery patients may include: 1) defining optimal surgical approaches, 2) identification of biological and genetic differences that influence development of comorbidities and outcomes of surgery, and 3) utilizing this population as a model for study of the pathogenesis and response to treatment of obesity. We propose that the Bariatric Research Clinical Research Consortium (BSCRC) employ a comprehensive relational database that includes parameters readily available to all Clinical Centers (CCs), such as basic anthropometrics, measures of body composition, clinical and surgical history, and recording of a quantitative comorbidity scale. This scale scores each of 17 comorbidities related to obesity, including diabetes, hypertension, and hyperlipidemia, and utilizes treatment as a gauge for the severity of symptoms. Further refinement to the comorbidity scale grading may be required by BSCRC participants. This scale will enable comorbidities to be correlated with mRNA expression profiles and endocrine response. UC Davis proposes two specific protocols for conduct by the BSCRC. The short term protocol will measure, using quantitative PCR, the mRNA expression level of obesity related genes in the subcutaneous and omental fat, liver, and intestine of bariatric surgery patients at the time of operation. Measures of body composition including the distribution of body fat, endocrine response to gastric bypass, and the clinical comorbidity scores will allow detailed phenotyping of the subjects from the time of operation to timepoints 2 years post-op. This will be an important initial step towards understanding the variation of comorbidity occurrence between subjects of similar adiposity. The longer term protocol will be a 3-5 year longitudinal study of the response to gastric bypass in relation to hormone activity, body composition, and physical activity. At this phase, correlation with the preoperative genetic and endocrine markers derived in the short term study, as well as history of comorbidity scores, would identify those patients who would most benefit from gastric bypass. This and other data accumulated by the BSCRC will provide a basis for establishment of further studies of obesity comorbidities and their response to surgical treatment.