Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in MASLD

Steatosis of Liver Clinical Trial

Official title:

Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in Metabolic Dysfunction-associated Steatotic Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453239
• Other study ID #: Soh-Med-24-04-05MD
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Sohag University
• Contact: omneya deyaa, MD
• Phone: 01126826122
• Email: omnia_aboalwafa[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the diagnostic significance of serum pro-NT in MASLD and ability to differentiate between early and advanced steatosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• (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.

Related Conditions & MeSH terms

• Fatty Liver
• Steatosis of Liver

Intervention

Diagnostic Test:
• Pro-Neurotensin level as a Serum Biomarker
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (2)

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. — View Citation

Villar 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline