Steatosis of LiverNCT06453239
Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in MASLD
An observational study of Steatosis of Liver, run by Sohag University.
Trial summary
To assess the diagnostic significance of serum pro-NT in MASLD and ability to differentiate between early and advanced steatosis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Steatosis of Liver
- What is being tested?
- Pro-Neurotensin level as a Serum Biomarker
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 80 asymptomatic adults will be randomly recruited from relatives of patients in Tropical Medicine and Gastroenterology outpatient clinic or the inpatient section of the department. Participants will be categorized as MASLD patients if their radiological investigation (By abdominal ultrasound examination and Fibroscan) shows the criteria of fatty liver (including 40 adults) or non-MASLD (controls) if they don't show these criteria (including 40 adults).
Who may be able to join
- Asymptomatic adults were randomly recruited from relatives of patients in Tropical Medicine and Gastroenterology Outpatient Clinic or the Inpatient Section of the department. Participants were categorized as MASLD patients if their abdominal US examination showed the criteria of fatty liver as described later or Non-MASLD (Controls) if they did not show these criteria.
Who cannot join
- (i) Patients aged <18 years or >75 years. (ii) History of Alcohol consumption. (iii) A diagnosis of liver diseases other than MASLD, including viral hepatitis, drug-induced liver injury, clinically suspected cases of autoimmune liver disease, Wilson's diseases, primary biliary cholangitis.
- The control group had no illness to cause any inflammation; no usage of alcohol, drug, or herbal substances; no history of previous liver diseases; and was negative for viral hepatitis serology tests and had completely normal liver US.
Trial locations and contacts
No sites are listed yet.
Khairy Hammam, professor contact
About this study
Official title: Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in Metabolic Dysfunction-associated Steatotic Liver Disease
To assess the diagnostic significance of serum pro-NT in MASLD and ability to differentiate between early and advanced steatosis.
- Conditions
- Steatosis of Liver
- Being tested
- Pro-Neurotensin level as a Serum Biomarker
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-Neurotensin level as a Serum BiomarkerDiagnostic test
Pro-Neurotensin mediates the development of fatty liver disease. Neurotensin (NT) is a 13-amino acid peptide secreted by the neuroendocrine cells of the small intestine in response to fat ingestion, which facilitates fatty acid absorption through the gut in relation to food lipid content.
| Study group | Role | What they receive |
|---|---|---|
| 40 adults categorized as MASLD patients | Not described Receives: Diagnostic Test: Pro-Neurotensin level as a Serum Biomarker | |
| 40 adults of non-MASLD (controls) | Not described Receives: Diagnostic Test: Pro-Neurotensin level as a Serum Biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in Metabolic Dysfunction-associated Steatotic Liver Disease
To assess the diagnostic significance of serum pro-Neurotensin in metabolic dysfunction-associated steatotic liver disease and ability to differentiate between early and advanced steatosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Steatosis of 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Aboelwafa, Sohag University
- Investigators
- Reem Mahmoud, lecturer, Study director, Sohag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453239
- Sponsor's protocol ID
- Soh-Med-24-04-05MD
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohamed AA, Abo-Elmatty DM, Ezzat O, Mesbah NM, Ali NS, Abd El Fatah AS, Alsayed E, Hamada M, Hassnine AA, Abd-Elsalam S, Abdelghani A, Hassan MB, Fattah SA. Pro-Neurotensin as a Potential Novel Diagnostic Biomarker for Detection of Nonalcoholic Fatty Liver Disease. Diabetes Metab Syndr Obes. 2022 Jun 22;15:1935-1943. doi: 10.2147/DMSO.S365147. eCollection 2022.
PubMed 35769889Villar B, Bertran L, Aguilar C, Binetti J, Martinez S, Sabench F, Real M, Riesco D, Paris M, Del Castillo D, Richart C, Auguet T. Circulating Levels of Pro-Neurotensin and Its Relationship with Nonalcoholic Steatohepatitis and Hepatic Lipid Metabolism. Metabolites. 2021 Jun 10;11(6):373. doi: 10.3390/metabo11060373.
PubMed 34200577
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in Metabolic Dysfunction-associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT06453239
- Acronym / sponsor ID
- Soh-Med-24-04-05MD
- Conditions
- Steatosis of Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 11 Jun 2024 (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.
To assess the diagnostic significance of serum pro-NT in MASLD and ability to differentiate between early and advanced steatosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 adults categorized as MASLD patients | – | Diagnostic Test: Pro-Neurotensin level as a Serum Biomarker |
| 40 adults of non-MASLD (controls) | – | Diagnostic Test: Pro-Neurotensin level as a Serum Biomarker |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 80 asymptomatic adults will be randomly recruited from relatives of patients in Tropical Medicine and Gastroenterology outpatient clinic or the inpatient section of the department. Participants will be categorized as MASLD patients if their radiological investigation (By abdominal ultrasound examination and Fibroscan) shows the criteria of fatty liver (including 40 adults) or non-MASLD (controls) if they don't show these criteria (including 40 adults).
Key inclusion criteria (1 listed)
- Asymptomatic adults were randomly recruited from relatives of patients in Tropical Medicine and Gastroenterology Outpatient Clinic or the Inpatient Section of the department. Participants were categorized as MASLD patients if their abdominal US examination showed the criteria of fatty liver as described later or Non-MASLD (Controls) if they did not show these criteria.
Key exclusion criteria (2 listed)
- (i) Patients aged <18 years or >75 years. (ii) History of Alcohol consumption. (iii) A diagnosis of liver diseases other than MASLD, including viral hepatitis, drug-induced liver injury, clinically suspected cases of autoimmune liver disease, Wilson's diseases, primary biliary cholangitis.
- The control group had no illness to cause any inflammation; no usage of alcohol, drug, or herbal substances; no history of previous liver diseases; and was negative for viral hepatitis serology tests and had completely normal liver US.
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 |
|---|---|---|
| Pro-Neurotensin level as a Serum BiomarkerPro-Neurotensin mediates the development of fatty liver disease. Neurotensin (NT) is a 13-amino acid peptide secreted by the neuroendocrine cells of the small intestine in response to fat ingestion, which facilitates fatty acid absorption through the gut in relation to food lipid content. | Diagnostic test | 40 adults categorized as MASLD patients, 40 adults of non-MASLD (controls) |
Primary outcome
Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in Metabolic Dysfunction-associated Steatotic Liver Disease
Time frame: Baseline
To assess the diagnostic significance of serum pro-Neurotensin in metabolic dysfunction-associated steatotic liver disease and ability to differentiate between early and advanced steatosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 35769889Mohamed AA, Abo-Elmatty DM, Ezzat O, Mesbah NM, Ali NS, Abd El Fatah AS, Alsayed E, Hamada M, Hassnine AA, Abd-Elsalam S, Abdelghani A, Hassan MB, Fattah SA. Pro-Neurotensin as a Potential Novel Diagnostic Biomarker for Detection of Nonalcoholic Fatty Liver Disease. Diabetes Metab Syndr Obes. 2022 Jun 22;15:1935-1943. doi: 10.2147/DMSO.S365147. eCollection 2022.
- Background: PubMed 34200577Villar B, Bertran L, Aguilar C, Binetti J, Martinez S, Sabench F, Real M, Riesco D, Paris M, Del Castillo D, Richart C, Auguet T. Circulating Levels of Pro-Neurotensin and Its Relationship with Nonalcoholic Steatohepatitis and Hepatic Lipid Metabolism. Metabolites. 2021 Jun 10;11(6):373. doi: 10.3390/metabo11060373.
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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. This study is not recruiting at the moment.
Khairy Hammam, professor contact
Reem Mahmoud, lecturer study director
Sohag
Questions about this trial
What is this clinical trial studying?
An observational study of Steatosis of Liver, 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?
The sponsor lists 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact omneya deyaa, MD (01126826122, omnia_aboalwafa@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in Metabolic Dysfunction-associated Steatotic Liver Disease (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453239, which also lists 2 linked publications.
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 11 Jun 2024.