New Biomarkers for Non-Invasive Diagnosis and Prognosis of Non-Alcoholic Fatty Liver Disease
This study aims to identify and validate new soluble biomarkers for liver fibrosis, which can be used in non-invasive clinical tests for the diagnosis and prognosis of Non-Alcoholic Fatty Liver Disease.
Data Collection
Collected from today forward - ProspectiveBody Weight+17
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 22, 2015
Actual date on which the first participant was enrolled.This study focuses on Non-alcoholic Fatty Liver Disease (NAFLD), a common condition linked to unhealthy lifestyles, such as overeating and lack of physical activity. Currently, there are no effective medicines for NAFLD, and the best way to prevent or improve it is through a healthier lifestyle. However, many people struggle to adapt to these changes. The study aims to identify new biomarkers, or indicators, of NAFLD. These biomarkers could lead to the development of non-invasive tests for early detection of the disease, which could motivate individuals to change their lifestyle. The study is particularly interested in finding biomarkers that can diagnose and predict the progression of NAFLD. The study will be conducted in three phases. First, the researchers will use computer programs to analyze a large amount of genetic and protein data to identify potential biomarkers. Then, they will collect blood and liver samples from patients undergoing bariatric surgery, and measure the levels of these potential biomarkers. Finally, they will correlate the levels of these biomarkers with the severity of the disease, as determined by blood tests, liver biopsy, and imaging techniques. The study plans to enroll 62 patients and will take approximately 12 months to complete.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location