Heritability of Fatty Liver as Measured by MRI: a Cross Sectional Study of Twins and Family Members
2021年5月3日 更新者:Rohit Loomba、University of California, San Diego
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the United States.
The cause of NAFLD is poorly defined but is thought to involve complex interactions of genetic and environmental factors.
NAFLD is often associated with the traits of the metabolic syndrome including diabetes, high cholesterol or elevated blood pressure.
Currently, there are no accurate noninvasive means of evaluating NAFLD and its more serious form which includes inflammation that may lead to severe scarring in the liver.
The goal of this study is to evaluate shared genetic factors that underlie NAFLD and features of the metabolic syndrome as determined by blood work and radiographic studies in a cohort of twins and first degree relatives.
研究概览
地位
招聘中
条件
详细说明
Following an information session during which the primary consent document, a genetic sampling consent document and the UCSD HIPPA forms are reviewed, discussed and signed, the following tests and procedures will be done. For each subject, the study visit will be for 3-4 hours.
- Subjects will undergo a detailed history, physical examination, anthropometrics and vital signs including blood pressure and pulse. Standardized questionnaires including the Alcohol Use Disorders Identification Tests (AUDIT) and Skinner Lifetime Drinking History will be used to identify alcohol use as a cause of fatty liver disease. A trained investigator will measure waist/hip ratio at the same time as other measures are taken. The Body Mass Index (BMI) will be as calculated by measuring each subject's weight (Kg) and height (m) with empty bowel and bladder and using the formula: BMI = weight (kg)/ height (m)2.
- Blood tests: Participants will undergo phlebotomy, after an overnight fast, for complete metabolic panel (including liver function tests), complete blood count, protime, lipid panel, free fatty acids, serum insulin, hemoglobin A1C, fasting glucose, hepatitis B surface antigen, hepatitis C antibody, prothrombin time and HIV. 30ml of blood will be collected: including 5ml of serum banking, 5ml of plasma banking, 5ml of DNA banking, and 15ml for planned labs as listed above. Plasma will be stored for adipocytokines and testing of novel genes or biomarkers for NALFD in later studies. Fasting plasma glucose and plasma insulin levels will be obtained. Insulin resistance will be measured by HOMA-IR, the homeostasis assessment model of insulin resistance, where HOMA-IR (mmol/L x µU/ml) = fasting glucose (mmol/L) x fasting insulin (µU/ml)/22.5). The participants will be required to provide a stool and urine sample as well.
- A urine pregnancy test will be performed for all women of childbearing age. Women who have had hysterectomies are excluded from pregnancy testing. If the pregnancy test is positive, the patient will not be enrolled in the study.
- The patient will undergo magnetic resonance imaging for hepatic fat fraction.
研究类型
观察性的
注册 (预期的)
500
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Archana Bhatt
- 电话号码:619-471-3915
- 邮箱:abhatt@ucsd.edu
学习地点
-
-
California
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San Diego、California、美国、92103
- 招聘中
- University of California, San Diego
-
接触:
- Archana R Bhatt
- 电话号码:619-471-3915
- 邮箱:abhatt@ucsd.edu
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Twins and first degree relatives (sibling-sibling or offspring-parent).
描述
Inclusion Criteria:
- Subjects must be at least 18 years of age
- The subject is willing and able to complete all procedures and observations specified in the protocol
- The subject has been fully informed and has personally signed and dated the written Informed Consent/Assent and Health Insurance Portability and Accountability Act (HIPAA) provisions.
Exclusion Criteria:
- The subject is a female who is pregnant or nursing.
Contraindications to MRI:
- The subject has any contraindication to MR imaging, such as patients with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field.
- The subject has a history of extreme claustrophobia.
- The subject cannot fit inside the MR scanner cavity
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Rohit Loomba、UCSD
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年8月1日
初级完成 (预期的)
2021年8月1日
研究完成 (预期的)
2021年8月1日
研究注册日期
首次提交
2012年7月16日
首先提交符合 QC 标准的
2012年7月17日
首次发布 (估计)
2012年7月18日
研究记录更新
最后更新发布 (实际的)
2021年5月6日
上次提交的符合 QC 标准的更新
2021年5月3日
最后验证
2021年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.