NCT07834905

Brief Summary

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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2028

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

SII SIRICONUTMASLDPNIFibroScanNAFLD fibrosis score

Outcome Measures

Primary Outcomes (1)

  • Correlation Between Prognostic Nutritional Index PNI and MASLD Presence

    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

Secondary Outcomes (3)

  • Predictive Value of CBC-Derived Inflammatory Indices SIRI SII PIV for MASLD

    Baseline

  • Predictive Value of PLR NLR MPR PWR for Liver Fibrosis Severity

    Baseline

  • MASLD Fibrosis Score and FibroScan for Advanced Fibrosis

    Baseline

Study Arms (2)

MASLD

Participants diagnosed with metabolic dysfunction-associated steatotic liver disease.

Non-MASLD

Participants without metabolic dysfunction-associated steatotic liver disease.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 18 to 65 years
  • Written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver CirrhosisMalnutritionNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesFatty Liver

Study Officials

  • Hanan m Ahmed, prof

    Internal Medicine Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Yara M Saber, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 22, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

March 10, 2028

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share