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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Steatosis of Liver
• Intervention / Treatment: Diagnostic test: Pro-Neurotensin level as a Serum Biomarker

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: omneya deyaa, MD; Phone Number: 01126826122; Email: omnia_aboalwafa@med.sohag.edu.eg
• Study Contact Backup: Name: Khairy Hammam, professor; Phone Number: 01003064022

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
40 adults categorized as MASLD patients	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.
40 adults of non-MASLD (controls)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Reem Mahmoud, lecturer, Sohag

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: Soh-Med-24-04-05MD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No