Impact of Overt and Subclinical Hypothyroidism on Liver Fibrosis in Patients With MASLD
NCT07827430
Digestive System Diseases, Endocrine System Diseases
View Trial DetailsNCT Number: NCT07834905
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Predictive Value of Nutritional Indices and CBC-Derived Inflammatory Markers for Metabolic Dysfunction-Associated Steatotic Liver Disease
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