Biomarkers in the Diagnosis and Prognosis of NAFLD

NCT06098417 | Recruiting

• 1 other identifier: NALFD biomarkers
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Fibrosis is considered the leading cause of liver diseases and related mortality. Specifically, hepatic fibrosis is regarded as the consequence of reparative mechanisms initiated by hepatocytes in response to chronic damage. In Western countries, the main known etiologies include hepatitis (B and C), alcoholism, and non-alcoholic steatohepatitis (NASH). In particular, obesity is a determining factor in the onset and development of NASH. Alarming statistical data indicate that over 30% of the world's population is obese, and this eating disorder is increasingly affecting young people. NASH is a chronic disease that can present different degrees of fibrosis and, as the final stage, lead to the development of liver cirrhosis. Currently, the only accurate diagnostic and assessment system for this condition is liver biopsy, as there are no accurate non-invasive clinical tests available. The aim of this project is to identify (in silico) potential biomarkers involved in the development and progression of hepatic fibrosis and validate their presence and quantity in serum or plasma samples from obese patients (at-risk population). This would avoid the need for a liver biopsy and allow "at-risk" patients to undergo a simple ambulatory blood draw. Additionally, performing elastometry of the liver would allow for comparison of radiological results with laboratory findings.

Conditions

NAFLD; Obesity; Liver Fibrosis; Diabetes Mellitus, Type 2

Keywords

Nafld; Obesity; Biomarkers; Liver ultrasound; Liver elastography; Bariatric surgery; Tissue biopsy

Outcome Measures

Primary Outcomes (1)

• soluble biomarkers of liver fibrosis

  To identify (through in silico analysis) and validate new biomarkers that are useful for the diagnosis and prognosis of NAFLD, which can be used in non-invasive clinical tests.

  Time of enrollment. At baseline, before collecting liver biopsy during bariatric surgery

Secondary Outcomes (4)

• Follow-up

  6 -12 months after surgery

• Correlation analysis

  At baseline and 6-12 months after surgery

• Correlation analysis

  At baseline and 12 months after surgery

• Biobank

  At baseline and at the time of bariatric surgery

Interventions

Plasma test DIAGNOSTIC_TEST

IGF-2 (insulin-like growth factor 2)

Liver biopsy DIAGNOSTIC_TEST

Fibrosis and steatosis grade according to Brunt-Kleiner classification

Visceral adipose tissue biopsy DIAGNOSTIC_TEST

Presence of inflammation

Liver elastography DIAGNOSTIC_TEST

Grade of fibrosis according to Hamaguchi score

Blood test DIAGNOSTIC_TEST

Determination of surrogate based diagnostic tests/scores for liver fibrosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity eligible for bariatric surgery

You may qualify if:

• BMI\> 35 Eligible for bariatric surgery according to the current international guidelines (IFSO guidelines)

You may not qualify if:

• Patients affected by active liver viral infection
• Patient alcohol or drug addicted
• Incompetent patients

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Silvia Palmisano

Trieste, 34100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, liver specimen and visceral adipose tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Liver Cirrhosis; Diabetes Mellitus, Type 2

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Silvia Palmisano, MD

CONTACT

0403994152; spalmisano@units.it

Study Design

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

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: September 22, 2015
• Primary Completion: September 22, 2025
• Study Completion (Estimated): September 22, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)