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临床试验/CTRI/2024/04/066241
CTRI/2024/04/066241尚未招募不适用

Assessment Of Association Between APRI Score And FIB4 Score With Liver Fibrosis Among Diabetes Type 2 Patients In Medicine Department Of Sir Takhtsinhji Hospital Bhavnagar

Priteshkumar Patel1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
348
试验地点
1
主要终点
To assess the association between APRI score and FIB4 score with Liver Fibrosis among Diabetes Type 2 patients in medicine department of Sir Takhtsinhji hospital Bhavnagar

研究概览

简要总结

This study is a Prospective Observational Study used to assess the association between APRI score and FIB4 score with Liver Fibrosis among Diabetes Type 2 patients in medicine department of Sir Takhtsinhji hospital Bhavnagar

•Diabetes Mellitus Type 2 is a chronic, metabolic disease characterized by elevated levels of blood glucose. This disease affect all body systems, including the liver.

•

•Hyperglycemia, mainly caused by insulin resistance, affects the metabolism of lipids, carbohydrates and proteins and can lead to non-alcoholic fatty liver disease(NAFLD), which can further progress to non-alcoholic steatohepatitis(NASH), cirrhosis and, finally, hepatocellular carcinomas(rarely).

•Routine screening for Liver fibrosis is not currently recommended for patients with diabetes or otherwise increased risk in the absence of elevated liver transaminases or other evidence for liver disease.

•

•This reflects a lack of adequate, evidence-based methods for Liver fibrosis screening and also uncertainties about how to effectively treat Liver Fibrosis once diagnosed.

•

•it will be important to continuously re-evaluate the cost-effectiveness of screening. Since the rate of progression from simple steatosis (NAFL) to steatosis with associated inflammation and fibrosis (NASH) appears to be quite low.

•

•Patients at low risk for advanced fibrosis are followed-up every 2 years by repeating liver enzymes and fibrosis scores,

•whereas those at intermediate or high risk need to be referred to specialists to exclude other chronic liver diseases, to better assess disease severity and possibly to initiate specific therapy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All individuals with DM type 2 above the age of 18 years under Medicine Department, Sir T hospital for our study.

排除标准

  • 1.Secondary causes of fatty liver(Infective, Alcoholic, Genetic) 2.Hypothyroidism,CCF 3.Pregnant women 4.Individuals using/having used hepatotoxins (acetaminophen, methotrexate, nitrofurantoin, rifampicin & heavy metals).
  • 5.Thrombocytopenia because of other causes.

结局指标

主要结局

To assess the association between APRI score and FIB4 score with Liver Fibrosis among Diabetes Type 2 patients in medicine department of Sir Takhtsinhji hospital Bhavnagar

时间窗: 6 months

次要结局

  • 1.To assess age and gender wise distribution of liver fibrosis using same scoring system in DM type 2 patients.(2.To establish the relation between duration of type 2 DM and liver fibrosis using different scoring system.)

研究者

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

Dr Priteshkumar Patel

Sir Takhatsinhji General Hospital Bhavnagar

研究点 (1)

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