PREVALENCE AND PREDICTORS OF NONALCOHOLIC FATTY LIVER DISEASE (NAFLD) IN VETERANS

退伍军人中非酒精性脂肪肝 (NAFLD) 的患病率和预测因素

• 批准号: 10038804
• 负责人: Hashem B El-Serag
• 金额: --
• 依托单位: MICHAEL E DEBAKEY VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-10-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10038804
• 关键词: Acids; Address; Adult; Affect; Age; Alcohols; Algorithms; Biochemical; Biological Markers; Blood Tests; Blood specimen; Body Weight decreased; Body fat; Body mass index; Calibration; Caring; Cirrhosis; Clinic; Clinical; Clinical Pathways; Clinical Practice Guideline; Clinical Trials; Complication; Cross-Sectional Studies; Cytokeratin-18 Staining Method; Data; Data Set; Detection; Diabetes Mellitus; Diagnosis; Dietitian; Discrimination; Disease; Disease stratification; Enrollment; Ethnic Origin; Exercise; Family; Fatty Liver; Fatty acid glycerol esters; Female; Fibrosis; Gender; Genetic; Healthcare; Healthcare Systems; Hepatic; Histologic; ITGB2 gene; Incidence; Inflammation; Insulin Resistance; Intervention; Life Style; Literature; Liver; Liver Failure; Liver Fibrosis; Liver Function Tests; Liver diseases; Magnetic Resonance Imaging; Measures; Medical; Medical History; Medical center; Metabolic; Metabolic syndrome; Obesity; Patients; Pharmaceutical Preparations; Policies; Population; Predictive Factor; Prevalence; Prevention; Primary Health Care; Primary carcinoma of the liver cells; Probability; Prognosis; Progressive Disease; Protons; Questionnaires; Race; Recording of previous events; Research; Resource Allocation; Resources; Risk; Risk Factors; Sampling; Serology; Services; Severities; Severity of illness; Smoking; Staging; Testing; Time; United States Department of Veterans Affairs; Veterans; Veterans Health Administration; base; cancer transplantation; chronic liver disease; clinical care; clinical practice; cohort; cost; database design; density; disorder risk; elastography; health care settings; high risk; improved; liver biopsy; liver transplantation; male; military veteran; non-alcoholic fatty liver disease; nonalcoholic steatohepatitis; novel; obese person; predictive modeling; primary care setting; screening; serological marker; sex; study population; waist circumference

The objective of this application is to determine the burden of non-alcoholic fatty liver disease (NAFLD) among patients receiving primary care at the Department of Veterans Affairs (VA) health care system. NAFLD affects an estimated 20%-30% of the adult non-VA US population and is projected to become the main cause of end- stage liver disease in the next 10 years. NAFLD encompasses a histologic spectrum ranging from simple steatosis to non-alcoholic steatohepatitis (NASH). Around 20% of patients with NASH undergo fibrotic progression to cirrhosis, which increases risk of liver failure the risk of hepatocellular carcinoma. NAFLD is considered the hepatic complication of obesity and insulin resistance. Proper diagnosis of NAFLD and subsequent treatment (e.g., dietitian services) is associated with improved biochemical and histological features of NAFLD. There are also ongoing clinical trials with promising medications (e.g., obeticholic acid) for NASH. Given the veteran population is disproportionately affected by the main risk factors for NAFLD (e.g., diabetes, obesity), our central hypothesis is that the veteran population in primary care is particularly susceptible to a high burden from NAFLD. It is unclear whether the VA is currently equipped to deal with this costly disorder given the lack of basic information on the prevalence, determinants, and clinical recognition of NAFLD in the VA. Advances in magnetic resonance imaging (MRI) has revolutionized the diagnosis and severity staging of NAFLD, thus obviating the need for liver biopsy in most cases. However, the use of MRI for NAFLD screening in a primary care setting is impractical and expensive. There are no agreed upon clinical prediction rules, and none that is tested in VA settings. We will address our hypothesis by conducting a probability-based cross-sectional study of 1000 veterans (500 males and 500 females) enrolled in the VA for their primary healthcare. Specific Aim #1: To determine the overall and race- and sex- specific prevalence of NAFLD (and Advanced Hepatic Fibrosis) using highly sensitive and specific MRI criteria in a large and representative sample of veterans enrolled at the Michael E. DeBakey VA Medical Center in Houston for their primary healthcare. This aim will be accomplished by combined use of liver magnetic resonance imaging proton density fat fraction (MRI-PDFF) and elastography (MRE). Specific Aim #2: To evaluate the association between presence and severity of NAFLD and potential risk factors, including demographic (gender, race/ethnicity), anthropometric (BMI, waist circumference, and body fat by bioimpedance analysis), clinical (medical history, family history, and medications), serologic (CD18), genetic (PNPLA3), biochemical (LFTs, serologic biomarkers of hepatic fibrosis and steatosis), metabolic (serologic markers of metabolic syndrome), and lifestyle (smoking, alcohol, exercise) factors. Specific Aim #3: Use the information on risk factors and biomarkers to construct and validate an algorithm that can be used at the primary care level to identify patients at high risk of NAFLD and NASH for further referral. The information on prevalence in different groups are essential for effective VA healthcare planning and resource allocation. The study will aid in the clinical recognition of NAFLD in the VA primary care setting using VA specific risk factors. Finally, our study will provide data needed to support future research to develop clinical pathways for detection and referral.

本申请的目的是确定非酒精性脂肪性肝病（NAFLD）在 在退伍军人事务部（VA）卫生保健系统接受初级保健的患者。NAFLD影响 估计有20%-30%的成年非VA美国人口，预计将成为最终的主要原因， 在未来10年内，肝脏疾病。NAFLD包括从单纯NAFLD到单纯NAFLD的组织学谱， 脂肪变性至非酒精性脂肪性肝炎（NASH）。大约20%的NASH患者发生纤维化 进展为肝硬化，这增加了肝衰竭的风险和肝细胞癌的风险。NAFLD是 考虑肥胖和胰岛素抵抗的肝脏并发症。正确诊断NAFLD， 随后的处理（例如，营养师服务）与改善的生化和组织学 NAFLD的特点也有正在进行的临床试验与有前途的药物（例如，奥贝胆酸） 纳什 考虑到退伍军人人群不成比例地受到NAFLD主要风险因素的影响（例如，糖尿病、 肥胖），我们的中心假设是，在初级保健的退伍军人人口特别容易受到 NAFLD的高负担。目前还不清楚退伍军人管理局目前是否有能力处理这种代价高昂的混乱局面 由于缺乏关于NAFLD的患病率、决定因素和临床识别的基本信息， 弗吉尼亚 磁共振成像（MRI）的进步彻底改变了脑梗死的诊断和严重程度分期。 NAFLD，因此在大多数情况下无需进行肝活检。然而，使用MRI进行NAFLD筛查 在初级保健环境中是不切实际和昂贵的。没有商定的临床预测规则， 没有在VA设置中进行测试。 我们将通过对1000名退伍军人（500名 男性和500名女性）参加VA的初级保健。 具体目标#1：确定NAFLD的总体患病率以及种族和性别特异性患病率（以及晚期 肝纤维化），使用高灵敏度和特异性的MRI标准，在一个大的和有代表性的样本， 退伍军人参加了迈克尔E。休斯顿的DeBakey VA医疗中心提供初级医疗保健服务。这 联合应用肝脏磁共振成像质子密度脂肪分数 （MRI-PDFF）和弹性成像（MRE）。 具体目标#2：评估NAFLD的存在和严重程度与潜在风险之间的关联 因素，包括人口统计学（性别，种族/民族），人体测量学（BMI，腰围和身体 通过生物阻抗分析测定脂肪）、临床（病史、家族史和药物治疗）、血清学（CD 18）， 遗传（PNPLA 3）、生化（LFT、肝纤维化和脂肪变性的血清学生物标志物）、代谢 （代谢综合征的血清学标志物）和生活方式（吸烟、饮酒、锻炼）因素。 具体目标#3：使用风险因素和生物标志物的信息来构建和验证算法 可用于初级保健水平，以识别NAFLD和NASH高风险患者， 转诊。 不同人群的患病率信息对于有效的VA医疗保健计划至关重要， 资源配置该研究将有助于在VA初级保健环境中对NAFLD的临床识别， 特殊风险因素。最后，我们的研究将提供支持未来研究所需的数据， 检测和转诊的临床路径。