跳至主要内容
临床试验/CTRI/2024/10/075627
CTRI/2024/10/075627尚未招募不适用

The correlation between anthropometry, metabolic profile, laboratory profile, non invasive tests and Fibroscan in MASLD- Metabolic Dysfunction Associated Steatotic Liver Disease: A real world experience

未提供1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
1)To compare and correlate Non Invasive test and score – FIB 4/APRI/AST/ALT ratio /NFS with Fibroscan values – CAP /LSM

研究概览

简要总结

A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. De Silva S, et al, performed a retrospective study on patients with histologically confirmed NAFLD,  showed that blood test-based non-invasive scores are less accurate in South Asian patients, irrespective of metabolic parameters. (population- younger, had lower body mass index) however Transient elastography was equally and highly accurate in both ethnicities. Mathew et al. - retrospective observational analytical study of patients who had a liver biopsy with a diagnosis of NAFLD, in south India- NFS of >0.676 had a sensitivity of 68% and specificity of 100%, and an FIB-4 index of >2.67 had a sensitivity of 67% and specificity of 95.6 % in diagnosing Advance fibrosis. Ornelas et al. -The total accuracy of the Fibroscan was found to be 66% (21 “good” correlation, 11 “poor” correlation). The accuracy of non-alcoholic steatohepatitis (NASH) was 91% compared to 52% for non-NASH liver diseases. Spearman rank correlation between Fibroscan and liver biopsy in NASH patients was found to be both positive and significant (Spearman’s correlation  0.699, P  0.017).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Willingness to give consent and follow up •Fulfilling the criteria for MASLD •Patients with followup records available, with atleast one visit during the study period.

排除标准

  • •Cirrhosis patients •Decompensated chronic Liver disease •Pregnancy •Chronic viral hepatitis Infections •Hypotension/ shock •History of CAM intake •History of Hepatotoxic drug used in the last 3 months •Alcohol Used disorder.

结局指标

主要结局

1)To compare and correlate Non Invasive test and score – FIB 4/APRI/AST/ALT ratio /NFS with Fibroscan values – CAP /LSM

时间窗: 8 months

2)To compare and correlate anthropometry measurements with Fibroscan values – CAP /LSM

时间窗: 8 months

3)To compare the non Invasive tests- FIB 4/APRI/AST/ALT ratio /NFS and Fibroscan, pre and post treatment (after 6 months of standrard therapy).

时间窗: 8 months

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Mhasisielie Zumu

Madras Medical Mission Hospital

研究点 (1)

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