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临床试验/CTRI/2024/05/066754
CTRI/2024/05/066754已完成不适用

Clinical profile of non alcoholic fatty liver disease and significance of hsCRP

Sanju George1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Predict severity of Non

研究概览

简要总结

Justification for study: Non alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. The global prevalence of Non alcoholic fatty liver disease is estimated to be as high as one billion. Liver biopsy being the gold standard, is too invasive, there’s a chance of sampling error and costly. There is a pressing need for more viable non invasive markers of severity. Timely intervention can revert the disease progression and play a significant role in bringing down the morbidity associated with the disease

Detailed description of procedure / processes: All patients admitted to Kasturba Hospital in the study period who are diagnosed as grade 2 and grade 3 fatty infiltration on USG abdomen, who meet the inclusion, exclusion criteria will be recruited for the study. Written and informant consent will be taken from the participants before initiating the study. Anthropometric data, investigative data including hsC-reactive protein levels and elastoscan reports are obtained from the proforma. Non alcoholic fatty liver fibrosis score and FIB4 score will be calculated using parameters obtained from the proforma. The above data will be compared and analyzed. Outcome measures include significance of hsCRP in NAFLD in predicting severity of NAFLD, study clinical profile of NAFLD, accuracy of non-invasive scoring systems of NAFLD

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients admitted to Kasturba Hospital during the study period who’s USG shows grade 2 or 3 fatty infiltration of the liver.

排除标准

  • Patients with history of significant/hazardous levels of alcohol consumption (ie.
  • more than one drink per day in women and two drinks per day in men based on epidemiologic evidence that the prevalence of serum aminotransferase elevations increases when alcohol consumption habitually exceeds these levels.
  • In those studies, one drink was defined as having 10 g of ethanol and, thus, is equivalent to one can of beer, 4 oz of wine, or 1.5 oz (one shot) of distilled spirits.), Patients with Connective Tissue disorders, Patients with chronic kidney disease, Patients with acute or chronic Hepatitis B or C infections, Patients with recent history of trauma, Patients with malignancies.

结局指标

主要结局

Predict severity of Non

时间窗: At baseline

Alcoholic Fatty liver by using hsCRP

时间窗: At baseline

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Sanju George
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sanju George

Kasturba Medical College, Manipal academy of higher education

研究点 (1)

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