Fatty LiverMASLDNCT07636915
Association Between Fatty Liver and Inflammatory Biomarkers
An observational study of Fatty Liver, run by Sohag University at 1 site in Egypt.
Trial summary
The newly adapted definition for MASLD includes evidence for hepatic steatosis by imaging or biopsy with at least one of the five cardiometabolic criteria; BMI ≥ 25 kg/m2 (≥23 kg/m2 in Asian) or waist circumference >94 cm in men, >80 cm in women, fasting serum glucose ≥ 126 mg/dL or 2 hour post load glucose level ≥… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria: Patient older than 18 years were diagnosed with MASLD according to Delphi consensus criteria (Rinella et al., 2024). Attend to outpatient clinic of Tropical Medicine Department, Sohag University. Exclusion Criteria: 1. Significant alcohol consumption (>20 g/day for females, >30 g/day for males). 2. Other causes of chronic liver disease: * Viral hepatitis (HBV, HCV) * Autoimmune hepatitis. * Wilson's disease. * Hemochromatosis. * Drug-induced liver injury. 3. Active infection or acute inflammatory conditions. 4. Malignancy. 5. Pregnancy.
Who may be able to join
- Patient older than 18 years were diagnosed with MASLD according to Delphi consensus criteria (Rinella et al., 2024). Attend to outpatient clinic of Tropical Medicine Department, Sohag University
Who cannot join
- Significant alcohol consumption (>20 g/day for females, >30 g/day for males).
- Other causes of chronic liver disease:
- Viral hepatitis (HBV, HCV)
- Autoimmune hepatitis.
- Wilson's disease.
- Hemochromatosis.
Show all 10Show fewer
- Drug-induced liver injury.
- Active infection or acute inflammatory conditions.
- Malignancy.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Systemic Inflammatory Indexes and Metabolic Dysfunction Associated Steatotic Liver Disease
The newly adapted definition for MASLD includes evidence for hepatic steatosis by imaging or biopsy with at least one of the five cardiometabolic criteria; BMI ≥ 25 kg/m2 (≥23 kg/m2 in Asian) or waist circumference >94 cm in men, >80 cm in women, fasting serum glucose ≥ 126 mg/dL or 2 hour post load glucose level ≥ 140 mg/dL or HbA1c ≥ 5.7% or on treatment for type 2 diabetes mellitus ,blood pressure ≥130/85 mmHg or antihypertensive treatment, plasma triglycerides ≥ 150 mg/dL or on lipid lowering drug, and plasma HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women or on lipid lowering drug treatment (Rinella et al., 2024).
These metabolic factors contribute to disease progression from simple steatosis to metabolic dysfunction-associated steatohepatitis (MASH), advanced fibrosis, cirrhosis, and hepatocellular carcinoma (Eid et al., 2024).
While multiple biological pathways contribute to MASLD pathogenesis; systemic inflammation has emerged as a pivotal mechanism linking metabolic dysfunction to liver injury (Bessone et al., 2019)
Read the detailed description
These metabolic factors contribute to disease progression from simple steatosis to metabolic dysfunction-associated steatohepatitis (MASH), advanced fibrosis, cirrhosis, and hepatocellular carcinoma (Eid et al., 2024).
While multiple biological pathways contribute to MASLD pathogenesis; systemic inflammation has emerged as a pivotal mechanism linking metabolic dysfunction to liver injury (Bessone et al., 2019). Recently, inflammation indexes derived from blood cell counts have attracted considerable interest due to their cost effectiveness, simplicity, and ease of computation (Ma et al., 2024).
Neutrophil-to-Lymphocyte Ratio (NLR), an easily measurable parameter, serves as a comprehensive reflection of two distinct complementary immune pathways, encompassing innate (neutrophilic) and adaptive (lymphocyte) cellular unction as an inflammatory marker (Lobo et al., 2023). Platelet-to-Lymphocyte Ratio (PLR) is a novel hematologic inflammatory parameter that may provide insights into the development of inflammatory diseases to a certain extent. (Zhou et al ., 2021). The neutrophil-albumin ratio (NAR) combines data on chronic inflammation and metabolic conditions and demonstrates the best predictive performance for the risk of MASLD, with an AUC value of 0.813.(He et al., 2025) The systemic immune-inflammation index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI) combine data from several immune pathways, offering a more comprehensive evaluation of inflammatory status (Wang et., al.2023). In this study we will assess the association between these inflammatory indexes and MASLD.
- Conditions
- Fatty Liver
- Keywords
- MASLD
- Medical subject headings
- Fatty Liver
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 patients | Patients older than 18 years were diagnosed with MASLD according to Delphi consensus criteria , patients will undergo complete history , examination and the following investigations, including : CBC , lipid profile, serum creatinine , serology and abdominal ultrasound then inflammatory biomarkers will be calculated : * Neutrophil-to-Lymphocyte Ratio (NLR). * Platelet-to-Lymphocyte Ratio (PLR). * Neutrophil-to-Albumin Ratio (NPAR). * Systemic Immune-Inflammatory Index (SII)= (Platelet count × Neutrophil count) / Lymphocyte count. * Systemic Inflammatory Response Index (SIRI) = (Neutrophil count × Monocyte count) / Lymphocyte count. to evaluate inflammatory biomarkers in MASLD patients . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between systemic inflammatory indexes and MASLD
To evaluate the statistical correlation between different systemic inflammatory indexes (including NLR, PLR, NPAR, SII, and SIRI) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The correlation will be assessed using Pearson's or Spearman's correlation coefficients based on the normality of data distribution.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Nasser Mohamed, Sohag University
- Investigators
- Safaa Kh Abdalla, MD, Principal investigator, Sohag University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636915
- Sponsor's protocol ID
- Soh-Med-26-5-2MS
- Acronym
- MASLD
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Systemic Inflammatory Indexes and Metabolic Dysfunction Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07636915
- Acronym / sponsor ID
- MASLD / Soh-Med-26-5-2MS
- Conditions
- Fatty Liver
- Keywords
- MASLD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Jun 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.
The newly adapted definition for MASLD includes evidence for hepatic steatosis by imaging or biopsy with at least one of the five cardiometabolic criteria; BMI ≥ 25 kg/m2 (≥23 kg/m2 in Asian) or waist circumference >94 cm in men, >80 cm in women, fasting serum glucose ≥ 126 mg/dL or 2 hour post load glucose level ≥ 140 mg/dL or HbA1c ≥ 5.7% or on treatment for type 2 diabetes mellitus ,blood pressure ≥130/85 mmHg or antihypertensive treatment, plasma triglycerides ≥ 150 mg/dL or on lipid lowering drug, and plasma HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women or on lipid lowering drug treatment (Rinella et al., 2024).
These metabolic factors contribute to disease progression from simple steatosis to metabolic dysfunction-associated steatohepatitis (MASH), advanced fibrosis, cirrhosis, and hepatocellular carcinoma (Eid et al., 2024).
While multiple biological pathways contribute to MASLD pathogenesis; systemic inflammation has emerged as a pivotal mechanism linking metabolic dysfunction to liver injury (Bessone et al., 2019)
Detailed description
These metabolic factors contribute to disease progression from simple steatosis to metabolic dysfunction-associated steatohepatitis (MASH), advanced fibrosis, cirrhosis, and hepatocellular carcinoma (Eid et al., 2024).
While multiple biological pathways contribute to MASLD pathogenesis; systemic inflammation has emerged as a pivotal mechanism linking metabolic dysfunction to liver injury (Bessone et al., 2019). Recently, inflammation indexes derived from blood cell counts have attracted considerable interest due to their cost effectiveness, simplicity, and ease of computation (Ma et al., 2024).
Neutrophil-to-Lymphocyte Ratio (NLR), an easily measurable parameter, serves as a comprehensive reflection of two distinct complementary immune pathways, encompassing innate (neutrophilic) and adaptive (lymphocyte) cellular unction as an inflammatory marker (Lobo et al., 2023). Platelet-to-Lymphocyte Ratio (PLR) is a novel hematologic inflammatory parameter that may provide insights into the development of inflammatory diseases to a certain extent. (Zhou et al ., 2021). The neutrophil-albumin ratio (NAR) combines data on chronic inflammation and metabolic conditions and demonstrates the best predictive performance for the risk of MASLD, with an AUC value of 0.813.(He et al., 2025) The systemic immune-inflammation index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI) combine data from several immune pathways, offering a more comprehensive evaluation of inflammatory status (Wang et., al.2023). In this study we will assess the association between these inflammatory indexes and MASLD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASLD patients | – | –Patients older than 18 years were diagnosed with MASLD according to Delphi consensus criteria , patients will undergo complete history , examination and the following investigations, including : CBC , lipid profile, serum creatinine , serology and abdominal ultrasound then inflammatory biomarkers will be calculated : * Neutrophil-to-Lymphocyte Ratio (NLR). * Platelet-to-Lymphocyte Ratio (PLR). * Neutrophil-to-Albumin Ratio (NPAR). * Systemic Immune-Inflammatory Index (SII)= (Platelet count × Neutrophil count) / Lymphocyte count. * Systemic Inflammatory Response Index (SIRI) = (Neutrophil count × Monocyte count) / Lymphocyte count. to evaluate inflammatory biomarkers in MASLD patients . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria: Patient older than 18 years were diagnosed with MASLD according to Delphi consensus criteria (Rinella et al., 2024). Attend to outpatient clinic of Tropical Medicine Department, Sohag University. Exclusion Criteria: 1. Significant alcohol consumption (>20 g/day for females, >30 g/day for males). 2. Other causes of chronic liver disease: * Viral hepatitis (HBV, HCV) * Autoimmune hepatitis. * Wilson's disease. * Hemochromatosis. * Drug-induced liver injury. 3. Active infection or acute inflammatory conditions. 4. Malignancy. 5. Pregnancy.
Key inclusion criteria (1 listed)
- Patient older than 18 years were diagnosed with MASLD according to Delphi consensus criteria (Rinella et al., 2024). Attend to outpatient clinic of Tropical Medicine Department, Sohag University
Key exclusion criteria (10 listed)
- Significant alcohol consumption (>20 g/day for females, >30 g/day for males).
- Other causes of chronic liver disease:
- Active infection or acute inflammatory conditions.
- Malignancy.
- Pregnancy.
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 systemic inflammatory indexes and MASLD
Time frame: At enrollment
To evaluate the statistical correlation between different systemic inflammatory indexes (including NLR, PLR, NPAR, SII, and SIRI) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The correlation will be assessed using Pearson's or Spearman's correlation coefficients based on the normality of data distribution.
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 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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.
Safaa Kh Abdalla, MD principal investigator
Sohag University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 10 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Alaa N Mohamed, MBBCh (01140559397, alaa_naser_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between systemic inflammatory indexes and MASLD (time frame: At enrollment). 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 10 Jun 2026.