NAFLD, NASH - Nonalcoholic Steatohepatitis, Obesity, Obesity, Morbid
Conditions
Brief summary
It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common cause of chronic liver disease due to an increase in the prevalence of obesity. The development of NASH leads to an increase in morbidity and mortality. Since patients with obesity are at an increased risk of NASH, the aim of this trial is to assess the prevalence of NASH in this class of patients.
Interventions
PROCEDURELiver biopsy
Biopsy of the liver to assess for Non-alcoholic steatohepatitis
Sponsors
Catholic University of the Sacred Heart
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 19 and 69 years
Exclusion criteria
* Pregnancy * Active cancer * End stage renal failure * End stage liver failure * Being unable to understand and sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of NASH | 6 months | Prevalence of NASH in a cohort of patients with different classes of obesity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of glycemic profile | 6 months | Assessment of fasting glucose |
| Assessment of glycated hemoglobin | 6 months | Assessment of glycated hemoglobin |
| Assessment of lipid profile | 6 months | Assessment of triglycerides, total cholesterol, LDL and HDL cholesterol |
| Assessment of insulin | 6 months | Assessment of fasting insulin |
| Assessment of metabolic profile | 6 months | Assessment of HOMA-IR index |
| Assessment of liver enzymes | 6 months | Assessment of AST, ALT, GGT |
Countries
Italy
Outcome results
None listed