Liver FibrosisNCT07834905
Nutritional Indices and Inflammatory Markers in MASLD
An observational study of Liver Fibrosis and Malnutrition, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fibrosis, Malnutrition, Non-Alcoholic Fatty Liver Disease
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 10 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-65 years attending Assiut University Hospitals, divided into those with MASLD and those without MASLD.
Who may be able to join
- Age 18 to 65 years
- Written informed consent
Who cannot join
- Acute infection
- Major surgery or recent trauma within the last 6 months
- Known malignancy
- Previous history of bariatric surgery
- History of liver cirrhosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- SII SIRI, CONUT, MASLD, PNI, FibroScan, NAFLD fibrosis score
- Medical subject headings
- Liver Cirrhosis, Malnutrition, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MASLD | Participants diagnosed with metabolic dysfunction-associated steatotic liver disease. | |
| Non-MASLD | Participants without metabolic dysfunction-associated steatotic liver disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (3)
Predictive Value of CBC-Derived Inflammatory Indices SIRI SII PIV for MASLD
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
Measured: Baseline
Predictive Value of PLR NLR MPR PWR for Liver Fibrosis Severity
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
Measured: Baseline
MASLD Fibrosis Score and FibroScan for Advanced Fibrosis
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Mahmoud Saber Youssef, Assiut University
- Investigators
- Hanan m Ahmed, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834905
- Sponsor's protocol ID
- MASLD-Nutritional-Indices-Assi
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Nutritional Indices and CBC-Derived Inflammatory Markers for Metabolic Dysfunction-Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07834905
- Acronym / sponsor ID
- MASLD-Nutritional-Indices-Assi
- Keywords
- SII SIRI, CONUT, MASLD, PNI, FibroScan, NAFLD fibrosis score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 10 Mar 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASLD | – | –Participants diagnosed with metabolic dysfunction-associated steatotic liver disease. |
| Non-MASLD | – | –Participants without metabolic dysfunction-associated steatotic liver disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-65 years attending Assiut University Hospitals, divided into those with MASLD and those without MASLD.
Key inclusion criteria (2 listed)
- Age 18 to 65 years
- Written informed consent
Key exclusion criteria (5 listed)
- Acute infection
- Major surgery or recent trauma within the last 6 months
- Known malignancy
- Previous history of bariatric surgery
- History of liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Prognostic Nutritional Index PNI and MASLD Presence
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
3 secondary outcomes
Predictive Value of CBC-Derived Inflammatory Indices SIRI SII PIV for MASLD
Time frame: Baseline
Predictive Value of PLR NLR MPR PWR for Liver Fibrosis Severity
Time frame: Baseline
MASLD Fibrosis Score and FibroScan for Advanced Fibrosis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanan m Ahmed, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis and Malnutrition, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara M Saber, Resident (01005184823, yara.mahmoud401@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Prognostic Nutritional Index PNI and MASLD Presence (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.