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临床试验/NCT05974904
NCT05974904招募中不适用

Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study

Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2023年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
7,000
试验地点
1
主要终点
Controlled attenuation parameter

研究概览

简要总结

The goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD).

The main question[s] it aims to answer are:

[question 1] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD? [question 2] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?

详细描述

Background Inflammation is related to the occurrence and development of fatty liver. Our research aimed to investigate the link between an inflammatory indicator, high-sensitivity C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver disease (MAFLD).

Methods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis of participants from the NHANES database, respectively. The relationship between hsCAR and MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same methodology.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Total participants from NHANES 2017-2020
  • Participants diagnosed with MAFLD. Metabolic dysfunction-associated fatty liver disease (MAFLD) is the term used to describe hepatic steatosis in the presence of metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus.
  • Diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) HbA1c ≥ 6.5% (48 mmol/mol); (3) fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); (4) 2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L (200 mg/dL).
  • Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians
  • If presence of at least two metabolic risk abnormalities:
  • Waist circumference≥102/88 cm in Caucasian men and women (or≥90/80 cm in Asian men and women)
  • Blood pressure≥130/85 mmHg or specific drug treatment
  • Plasma triglycerides≥150 mg/dl (≥1.70 mmol/L) or specific drug treatment
  • Plasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment
  • Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl [5.6 to 6.9 mmol/L], or 2-hour post-load glucose levels 140 to 199 mg/dl [7.8 to 11.0 mmol] or HbA1c 5.7% to 6.4% [39 to 47 mmol/mol])
  • Homeostasis model assessment of insulin resistance score≥2.5
  • Plasma high-sensitivity C-reactive protein level >2 mg/L

排除标准

  • Liver ultrasound data not available
  • participants without complete clinical data
  • participants under 18 years old
  • participants with cancer.

结局指标

主要结局

Controlled attenuation parameter

时间窗: at baseline

Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis

次要结局

  • Liver stiffness measurement(at baseline)

研究者

发起方
Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tingqiu Wang

Principal Investigator

Chongqing Medical University

研究点 (1)

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