- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07834905
Nutritional Indices and Inflammatory Markers in MASLD
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Yara M Saber, Resident
- Telefonnummer: 01005184823
- E-post: yara.mahmoud401@med.aun.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adults aged 18-65 years attending Assiut University Hospitals, divided into those with MASLD and those without MASLD.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
MASLD
Participants diagnosed with metabolic dysfunction-associated steatotic liver disease. |
|
Non-MASLD
Participants without metabolic dysfunction-associated steatotic liver disease. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation Between Prognostic Nutritional Index PNI and MASLD Presence
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Predictive Value of CBC-Derived Inflammatory Indices SIRI SII PIV for MASLD
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Hanan m Ahmed, prof, Internal Medicine Department, Assiut University Hospitals
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MASLD-Nutritional-Indices-Assi
Plan for individuelle deltakerdata (IPD)
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