Non-invasive screening of diabetics for advanced fibrosis due to NAFLD
对糖尿病患者进行 NAFLD 引起的晚期纤维化的无创筛查
基本信息
- 批准号:10392426
- 负责人:
- 金额:$ 56.71万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-05-20 至 2024-04-30
- 项目状态:已结题
- 来源:
- 关键词:AddressAdultAffectAgeAreaBiological MarkersBiopsyCessation of lifeChronicCirrhosisClinicalCost Effectiveness AnalysisCosts and BenefitsDataDetectionDiagnosticDiagnostic testsDiseaseDisease ProgressionEarly identificationEquilibriumExhibitsFatty LiverFatty acid glycerol estersFibrosisFutureGoalsGoldHepaticImageInterventionKnowledgeLiverLiver FibrosisLongitudinal StudiesMagnetic Resonance ImagingModelingMonitorNon-Insulin-Dependent Diabetes MellitusParticipantPatientsPhenotypePilot ProjectsPopulationPractice GuidelinesPrevalencePrimary carcinoma of the liver cellsPrognosisProspective cohortProtonsReference StandardsReproducibilityRiskRisk FactorsSerumSubgroupTechnologyTestingTimeUncertaintybaseclinical practicecohortcostcost effectivecost effectivenesscost-effectiveness evaluationdensitydiabeticdiagnostic accuracydiagnostic screeningdiagnostic strategyelastographyend stage liver diseasehigh risk populationimaging biomarkerimaging modalityliver biopsyliver stiffnessliver transplantationmathematical modelmortality risknon-alcoholic fatty liver diseasenon-invasive imagingnonalcoholic steatohepatitisprimary outcomeroutine screeningscreening
项目摘要
PROJECT SUMMARY
Nonalcoholic fatty liver disease (NAFLD) affects an estimated 30% of the adult U.S. population1-3. Several
studies suggest type 2 diabetes mellitus (T2DM) is a strong independent risk factor for NAFLD progression to
NASH and liver fibrosis4-13 and confers an increased risk of hepatocellular carcinoma14-18. However, current
AASLD NAFLD practice guidelines state routine screening for NAFLD in high-risk groups such as the T2DM
population “is not advised at this time because of uncertainties surrounding diagnostic tests and treatment
options, along with lack of knowledge related to long-term benefits and cost-effectiveness of screening”19. Here,
we propose to use advanced magnetic resonance imaging (MRI) to study and monitor NAFLD and fibrosis in a
prospective cohort of T2DM patients. Our overarching goal is to collect the necessary evidence to make an
informed decision on whether screening the T2DM population for advanced fibrosis due to NAFLD is advisable
and cost-effective. We will also define the best screening approach, balancing diagnostic accuracy and
availability with cost. Our group has developed and clinically validated two advanced magnetic resonance
imaging (MRI) modalities for non-invasive assessment of liver fat and fibrosis: MRI Proton Density Fat Fraction
(MRI-PDFF) and MR Elastography (MRE). Using these advanced technologies, we will accurately phenotype
T2DM patients to assess their risk of advanced fibrosis and monitor rates of NAFLD progression in this
population. To achieve our goal, our specific aims are:
Aim 1: Test the hypothesis that MRE and VCTE can reliably and non-invasively detect the presence of
advanced fibrosis due to NAFLD in T2DM patients. To evaluate diagnostic approaches for screening the
T2DM population, here we will use MRI-PDFF and MRE to accurately estimate the prevalence of NAFLD and
advanced fibrosis, respectively. The primary outcome will be advanced fibrosis, as defined by MRE ≥ 3.63 kPa,
with additional confirmation by liver biopsy. MR-based assessments will be used as reference standards to
identify corresponding cut-off values for their transient elastography counterparts, VCTE and CAP.
Aim 2: Identify risk factors and biomarkers for rapid fibrosis progression in the T2DM population To
define which T2DM patients are most likely to show rapid fibrosis progression, we will longitudinally follow a
subset of study participants. We hypothesize that higher liver fat content at baseline (>15.7%) associates with
higher rate of liver stiffness progression in the T2DM population. We further hypothesize that those with higher
liver stiffness have a greater risk of progression, as defined as MRE > 4.67 kPa, or cirrhosis. We will also explore
risk factors and imaging- and serum-based biomarkers that may help identify fast progressors.
Aim 3: Test the hypothesis that screening T2DM patients for advanced fibrosis is cost-effective. Here,
we will identify whether, when and for which T2DM subgroups NAFLD screening benefits outweigh the risks.
项目总结
非酒精性脂肪性肝病(NAFLD)影响了大约30%的美国成年人1-3。几个
研究表明2型糖尿病(T2 DM)是NAFLD进展为
NASH和肝纤维化4-13,并增加患肝细胞癌的风险14-18。但是,当前
AASLD NAFLD实践指南规定了T2 DM等高危人群NAFLD的常规筛查
由于围绕诊断测试和治疗的不确定性,目前不建议使用“人群”
备选办法,以及缺乏与筛查的长期效益和成本效益有关的知识“19.
我们建议使用先进的磁共振成像(MRI)来研究和监测NAFLD和纤维化
T2 DM患者的前瞻性队列研究。我们的首要目标是收集必要的证据,以便
关于对T2 DM人群进行NAFLD引起的晚期纤维化筛查是否可取的知情决定
而且性价比高。我们还将定义最佳筛查方法,平衡诊断准确性和
有成本的可用性。我们的团队已经开发出并在临床上验证了两种先进的磁共振
无创性评估肝脏脂肪和纤维化的成像(MRI)方法:MRI质子密度脂肪分数
(MRI-PDFF)和MR弹性成像(MRE)。利用这些先进的技术,我们将准确地进行表型
T2 DM患者评估其晚期纤维化的风险并监测NAFLD进展率
人口。为了实现我们的目标,我们的具体目标是:
目的1:验证MRE和VCTE可以可靠和非侵入性地检测到
2型糖尿病患者非酒精性脂肪肝所致的晚期纤维化评估筛查疾病的诊断方法
在这里,我们将使用MRI-PDFF和MRE来准确地估计NAFLD和
分别为晚期纤维化。根据MRE≥3.63kpa的定义,主要结果将是晚期纤维化,
并通过肝脏活检进行进一步确认。基于MR的评估将被用作参考标准
确定对应的瞬时弹性图对应的截止值VCTE和CAP。
目标2:确定T2 DM人群中快速纤维化进展的危险因素和生物标记物
定义哪些T2 DM患者最有可能出现快速纤维化进展,我们将纵向跟踪
研究参与者的子集。我们假设,基线(15.7%)时较高的肝脏脂肪含量与
T2 DM人群中肝脏僵硬进展率较高。我们进一步假设,那些拥有更高
肝脏僵硬有更大的进展风险,定义为MRE>;4.67kpa,或肝硬变。我们还将探索
风险因素和基于成像和血清的生物标记物,可能有助于识别进展快的人。
目的3:验证对T2 DM患者进行晚期纤维化筛查具有成本效益的假设。这里,
我们将确定NAFLD筛查的益处是否大于风险,以及何时以及对哪些T2 DM亚组。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
ROHIT LOOMBA其他文献
ROHIT LOOMBA的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('ROHIT LOOMBA', 18)}}的其他基金
Role of liver fat and fibrosis in human CVD risk phenotypes.
肝脏脂肪和纤维化在人类心血管疾病风险表型中的作用。
- 批准号:
10262921 - 财政年份:2020
- 资助金额:
$ 56.71万 - 项目类别:
Role of liver fat and fibrosis in human CVD risk phenotypes.
肝脏脂肪和纤维化在人类心血管疾病风险表型中的作用。
- 批准号:
10461067 - 财政年份:2020
- 资助金额:
$ 56.71万 - 项目类别:
Non-invasive screening of diabetics for advanced fibrosis due to NAFLD
对糖尿病患者进行 NAFLD 引起的晚期纤维化的无创筛查
- 批准号:
10166841 - 财政年份:2020
- 资助金额:
$ 56.71万 - 项目类别:
Role of liver fat and fibrosis in human CVD risk phenotypes.
肝脏脂肪和纤维化在人类心血管疾病风险表型中的作用。
- 批准号:
10683992 - 财政年份:2020
- 资助金额:
$ 56.71万 - 项目类别:
QUS Technology for Diagnosis and Grading of Hepatic Steatosis in NAFLD
用于 NAFLD 肝脂肪变性诊断和分级的 QUS 技术
- 批准号:
9070671 - 财政年份:2015
- 资助金额:
$ 56.71万 - 项目类别:
QUS Technology for Diagnosis and Grading of Hepatic Steatosis in NAFLD
用于 NAFLD 肝脂肪变性诊断和分级的 QUS 技术
- 批准号:
8945356 - 财政年份:2015
- 资助金额:
$ 56.71万 - 项目类别:
相似海外基金
Co-designing a lifestyle, stop-vaping intervention for ex-smoking, adult vapers (CLOVER study)
为戒烟的成年电子烟使用者共同设计生活方式、戒烟干预措施(CLOVER 研究)
- 批准号:
MR/Z503605/1 - 财政年份:2024
- 资助金额:
$ 56.71万 - 项目类别:
Research Grant
RAPID: Affective Mechanisms of Adjustment in Diverse Emerging Adult Student Communities Before, During, and Beyond the COVID-19 Pandemic
RAPID:COVID-19 大流行之前、期间和之后不同新兴成人学生社区的情感调整机制
- 批准号:
2402691 - 财政年份:2024
- 资助金额:
$ 56.71万 - 项目类别:
Standard Grant
Early Life Antecedents Predicting Adult Daily Affective Reactivity to Stress
早期生活经历预测成人对压力的日常情感反应
- 批准号:
2336167 - 财政年份:2024
- 资助金额:
$ 56.71万 - 项目类别:
Standard Grant
Elucidation of Adult Newt Cells Regulating the ZRS enhancer during Limb Regeneration
阐明成体蝾螈细胞在肢体再生过程中调节 ZRS 增强子
- 批准号:
24K12150 - 财政年份:2024
- 资助金额:
$ 56.71万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Migrant Youth and the Sociolegal Construction of Child and Adult Categories
流动青年与儿童和成人类别的社会法律建构
- 批准号:
2341428 - 财政年份:2024
- 资助金额:
$ 56.71万 - 项目类别:
Standard Grant
Understanding how platelets mediate new neuron formation in the adult brain
了解血小板如何介导成人大脑中新神经元的形成
- 批准号:
DE240100561 - 财政年份:2024
- 资助金额:
$ 56.71万 - 项目类别:
Discovery Early Career Researcher Award
Laboratory testing and development of a new adult ankle splint
新型成人踝关节夹板的实验室测试和开发
- 批准号:
10065645 - 财政年份:2023
- 资助金额:
$ 56.71万 - 项目类别:
Collaborative R&D
Usefulness of a question prompt sheet for onco-fertility in adolescent and young adult patients under 25 years old.
问题提示表对于 25 岁以下青少年和年轻成年患者的肿瘤生育力的有用性。
- 批准号:
23K09542 - 财政年份:2023
- 资助金额:
$ 56.71万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Identification of new specific molecules associated with right ventricular dysfunction in adult patients with congenital heart disease
鉴定与成年先天性心脏病患者右心室功能障碍相关的新特异性分子
- 批准号:
23K07552 - 财政年份:2023
- 资助金额:
$ 56.71万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Issue identifications and model developments in transitional care for patients with adult congenital heart disease.
成人先天性心脏病患者过渡护理的问题识别和模型开发。
- 批准号:
23K07559 - 财政年份:2023
- 资助金额:
$ 56.71万 - 项目类别:
Grant-in-Aid for Scientific Research (C)














{{item.name}}会员




