Metabolic Dysfunction Associated Steatotic Liver DiseaseNCT07873749
Assessment of Circulating Leptin Levels in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
An observational study of Metabolic Dysfunction Associated Steatotic Liver Disease, run by Sohag University.
Trial summary
This study aims to evaluate circulating leptin levels in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Leptin is an adipokine involved in metabolism and inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction Associated Steatotic Liver Disease
- What is being tested?
- Serum Leptin Measurement
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending the Gastroenterology and Hepatology outpatient clinics or inpatient departments at Sohag University Hospitals, along with healthy volunteers matched for age and sex.
Inclusion Criteria: Patient older than 18 years diagnosed with MASLD according to Delphi consensus criteria In addition to a control group of healthy individuals, matched to them in age, sex and number.
-
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.
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
This study aims to evaluate circulating leptin levels in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Leptin is an adipokine involved in metabolism and inflammation. The study will assess the association between serum leptin levels and the presence or severity of MASLD compared to controls.
- Being tested
- Serum Leptin Measurement
- Keywords
- Leptin, Metabolic Dysfunction-Associated Steatotic Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Leptin MeasurementOther
evaluate circulating leptin levels in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
| Study group | Role | What they receive |
|---|---|---|
| MASLD Patient | Patients diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease Receives: Other: Serum Leptin Measurement | |
| Healthy controls | Not described Receives: Other: Serum Leptin Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Leptin Levels
Serum concentration of leptin measured in ng/mL using enzyme-linked immunosorbent assay (ELISA) in patients with MASLD compared to controls.
Measured: At baseline (upon study enrollment for each participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction Associated Steatotic Liver DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayada Arfat Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873749
- Sponsor's protocol ID
- Soh-Med-26-7-34MS
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Circulating Leptin Levels in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07873749
- Acronym / sponsor ID
- Soh-Med-26-7-34MS
- Keywords
- Leptin, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 14 Oct 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.
This study aims to evaluate circulating leptin levels in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Leptin is an adipokine involved in metabolism and inflammation. The study will assess the association between serum leptin levels and the presence or severity of MASLD compared to controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASLD Patient | – | Other: Serum Leptin MeasurementPatients diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease |
| Healthy controls | – | Other: Serum Leptin Measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Gastroenterology and Hepatology outpatient clinics or inpatient departments at Sohag University Hospitals, along with healthy volunteers matched for age and sex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Leptin Measurementevaluate circulating leptin levels in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) | Other | Healthy controls, MASLD Patient |
Primary outcome
Serum Leptin Levels
Time frame: At baseline (upon study enrollment for each participant)
Serum concentration of leptin measured in ng/mL using enzyme-linked immunosorbent assay (ELISA) in patients with MASLD compared to controls.
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 14 Oct 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction Associated Steatotic Liver Disease, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Oct 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 Mayada Arafat Mohamed, M.B.B.Ch., M.Sc. (01065597423, maiada.arfat@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Leptin Levels (time frame: At baseline (upon study enrollment for each participant)). 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 14 Oct 2026.