此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Nutritional Indices and Inflammatory Markers in MASLD

2026年9月17日 更新者:Yara Mahmoud Saber Youssef、Assiut University

Predictive Value of Nutritional Indices and CBC-Derived Inflammatory Markers for Metabolic Dysfunction-Associated Steatotic Liver Disease

Metabolic Dysfunction-Associated steatotic Liver Diseases MASLD affects approximately 25 percent of population. Systemic inflammation plays role in MASLD progression. This cross-sectional observational study at Assiut University Hospitals will include 180 participants aged 18 to 65 years divided into 90 with MASLD and 90 without MASLD over one year. Nutritional indices Prognostic Nutritional Index PNI and Controlling Nutritional Status CONUT score will be calculated from albumin lymphocyte count and cholesterol. CBC-based inflammatory indices SIRI SII PIV PWR PLR MPR WNR NLR will be calculated. MASLD fibrosis score based on age BMI diabetes AST ALT ratio platelet albumin and FibroScan will assess fibrosis F0-F2 versus F3-F4. Aim to evaluate correlation between PNI CONUT and MASLD and role of inflammatory indices as predictors for MASLD and advanced fibrosis.

研究概览

地位

尚未招聘

详细说明

MASLD has become global health problem 25 percent prevalence. Previous studies show relationship between MASLD and nutrition. Systemic inflammation is key link between metabolic dysregulation and hepatic fibrogenesis. Indices like SII SIRI PLR integrate neutrophil lymphocyte monocyte platelet counts reflecting immune-nutritional balance. PNI defined by lymphocytes and albumin linking immune competence with nutrition. CONUT reflects nutrition inflammation by albumin total cholesterol lymphocyte count.

This cross-sectional study will include patients 18-65 years at Assiut University Hospitals. Group 1 MASLD group 90 patients, Group 2 control non-MASLD 90 participants. Inclusion: 18-65 years. Exclusion: acute infection, major surgeries or trauma within last 6 months, known malignancy, previous bariatric surgery, liver cirrhosis. Sample size 180 calculated by G*Power version 3.1.9.7 correlation r 0.22 alpha 0.05 power 80 percent plus 10 percent dropout.

Study tools: medical history clinical examination anthropometric measurements weight height waist hip mid arm circumference BMI weight kg per height m2 WHO categories. MASLD fibrosis score: age BMI IFG diabetes AST ALT ratio platelet albumin cutoff less than -1.455 absence F0-F2 negative predictive 93 percent, -1.455 to 0.675 indeterminate, greater than 0.676 presence F3-F4 positive predictive 90 percent. FibroScan non-invasive ultrasound for fibrosis. Labs: CBC urea creatinine lipid profile LFTs. Indices: SIRI neutrophil x monocyte divided by lymphocyte, SII platelet x neutrophil divided by lymphocyte, PIV neutrophil x monocyte x platelet divided by lymphocyte, PWR platelet divided by WBC, PLR platelet divided by lymphocyte, platelet albumin ratio, MPR monocyte divided by platelet, WNR WBC divided by neutrophil, NLR neutrophil divided by lymphocyte. Analysis by SPSS version 22 Kolmogorov-Smirnov normality Chi-square t-test Mann Whitney p less than 0.05.

研究类型

观察性的

注册 (估计的)

180

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

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 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults aged 18-65 years attending Assiut University Hospitals, divided into those with MASLD and those without MASLD.

描述

Inclusion Criteria:

  • Age 18 to 65 years
  • Written informed consent

Exclusion Criteria:

  • Acute infection
  • Major surgery or recent trauma within the last 6 months
  • Known malignancy
  • Previous history of bariatric surgery
  • History of liver cirrhosis

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

  • 观测模型:CASE_CONTROL
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
MASLD

Participants diagnosed with metabolic dysfunction-associated steatotic liver disease.

Non-MASLD

Participants without metabolic dysfunction-associated steatotic liver disease.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Correlation Between Prognostic Nutritional Index PNI and MASLD Presence
大体时间:Baseline

PNI calculated as 10 x serum albumin g per dL plus 0.005 x total lymphocyte count per mm3 will be compared between MASLD and non-MASLD groups to evaluate association with MASLD presence

Baseline

次要结果测量

结果测量
措施说明
大体时间
Predictive Value of CBC-Derived Inflammatory Indices SIRI SII PIV for MASLD
大体时间:Baseline

SIRI neutrophil x monocyte divided by lymphocyte, SII platelet x neutrophil divided by lymphocyte, PIV neutrophil x monocyte x platelet divided by lymphocyte will be calculated and ROC curve analysis performed to detect role as predictors for MASLD

Baseline
Predictive Value of PLR NLR MPR PWR for Liver Fibrosis Severity
大体时间:Baseline

PLR platelet lymphocyte ratio, NLR neutrophil lymphocyte ratio, MPR monocyte platelet ratio, PWR platelet WBC ratio and platelet albumin ratio will be correlated with MASLD fibrosis score and FibroScan results to predict advanced fibrosis F3-F4 versus F0-F2

Baseline
MASLD Fibrosis Score and FibroScan for Advanced Fibrosis
大体时间:Baseline

MASLD NAFLD fibrosis score based on age BMI diabetes AST ALT ratio platelet albumin with cutoffs less than -1.455 absence and greater than 0.675 presence of significant fibrosis. FibroScan measurement of liver stiffness in kPa. Correlation with nutritional and inflammatory indices

Baseline

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

  • 学习椅:Hanan m Ahmed, prof、Internal Medicine Department, Assiut University Hospitals

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 (估计的)

2026年9月20日

初级完成 (估计的)

2027年9月20日

研究完成 (估计的)

2028年3月10日

研究注册日期

首次提交

2026年9月17日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月22日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅