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临床试验/NCT04462081
NCT04462081已完成不适用

Non Alcoholic Fatty Liver Disease and Coronary Heart Disease in Type 2 Diabetes Patients

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Percentage of Liver Fat as Measured by MRI-PDFF

研究概览

简要总结

To assess the feasibility in diabetics in a primary care setting of screening for NAFLD and advanced fibrosis, by using non-invasive magnetic resonance imaging (MRI) to estimate the hepatic proton density fat fraction (MRI-PDFF) and magnetic resonance elastography (MRE) to estimate hepatic stiffness.

详细描述

This is a prospective cohort study consisting of a one-time visit by diabetic patients with optional following liver biopsy. The aim of the study is to evaluate whether liver fat fraction and liver stiffness, as determined by magnetic resonance imaging, are associated with subclinical cardiovascular disease, as evaluated by coronary artery calcium scan in diabetics. During the visit, patients will undergo review of medical history, vitals (including body mass index, blood pressure), physical exam, blood work, urine collection, ECG, magnetic resonance imaging (MRI), including MR proton density fat fraction (MRI-PDFF) and MR elastography, ultrasound using acoustic radiation force impulse (ARFI) imaging, and computed tomography (CT) scan for coronary artery calcium scoring. Blood work will be sent for labs relevant to traits of metabolic syndrome including markers for diabetes (hemoglobin A1C, fasting glucose) and hyperlipidemia (lipid panel). Serum, plasma and whole blood will be stored for future studies. Results from history, physical exam, and radiographic imaging will be analyzed and if they indicate the presence of nonalcoholic steatohepatitis, patients will be offered an optional liver biopsy for further assessment. All patients will be invited to continue in the study and have follow-up visits every two years for a total duration of the study of 5 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of Liver Fat as Measured by MRI-PDFF

时间窗: Baseline

Evaluation of liver fat fraction and liver stiffness, as determined by magnetic resonance imaging, are associated with subclinical cardiovascular disease, as evaluated by coronary artery calcium scan in diabetics

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rohit Loomba

Associate Professor of Clinical Medicine

University of California, San Diego

研究点 (1)

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