Clinical trial

Biomarkers in the Diagnosis and Prognosis of NAFLD

Recruiting now · Not applicable · 1 countries · Registry ID NCT06098417

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionNAFLD, Obesity, Liver Fibrosis, Diabetes Mellitus, Type 2

Full registry criteria

Inclusion Criteria: BMI\> 35 Eligible for bariatric surgery according to the current international guidelines (IFSO guidelines) Exclusion Criteria: * Patients affected by active liver viral infection * Patient alcohol or drug addicted * Incompetent patients

Treatments and study arms

Plasma Test

Diagnostic Test

IGF-2 (insulin-like growth factor 2)

Plasma test

Diagnostic Test

SPARC (secreted protein acidic and rich in cysteine)

Plasma test

Diagnostic Test

EPICAN (heparan sulfate proteoglycan)

Plasma test

Diagnostic Test

EGFR (epidermal growth factor receptor)

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

Primary outcomes

soluble biomarkers of liver fibrosisTime of enrollment. At baseline, before collecting liver biopsy during bariatric surgery

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Silvia Palmisano🇮🇹 Trieste, Italy
Silvia Palmisano, MDContact
Pablo J Giraudi, PhDSub Investigator
Silvia Palmisano, MDPrincipal Investigator