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

NCT06453239 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-04-05MD
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Steatosis of Liver

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Pro-Neurotensin level as a Serum Biomarker DIAGNOSTIC_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.

40 adults categorized as MASLD patients; 40 adults of non-MASLD (controls)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sohag University: lead

Related 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.

  PMID: 35769889 BACKGROUND

• 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.

  PMID: 34200577 BACKGROUND

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Reem Mahmoud, lecturer

  Sohag

  STUDY DIRECTOR

Central Study Contacts

omneya deyaa, MD

CONTACT

01126826122; omnia_aboalwafa@med.sohag.edu.eg

Khairy Hammam, professor

CONTACT

01003064022

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06