NASH in Subjects With Different Classes of Obesity

• Conditions: NAFLD; Obesity; Obesity, Morbid; NASH - Nonalcoholic Steatohepatitis
• Interventions: Procedure: Liver biopsy

• Registration Number: NCT04653103
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study Start: 2020-11-20
• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-04
• Primary Completion: 2021-01-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18
• Study Completion: 2023-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with obesity	Liver biopsy	Subjects with different classes of obesity

Primary Outcome Measures

Name	Time	Method
Prevalence of NASH	6 months	Prevalence of NASH in a cohort of patients with different classes of obesity

Secondary Outcome Measures

Name	Time	Method
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 glycemic profile	6 months	Assessment of fasting glucose
Assessment of liver enzymes	6 months	Assessment of AST, ALT, GGT
Assessment of insulin	6 months	Assessment of fasting insulin
Assessment of metabolic profile	6 months	Assessment of HOMA-IR index

Trial Locations

Locations (2)

Catholic University School of Medicine; 🇮🇹 Rome, Italy

University of Rome Sapienza; 🇮🇹 Roma, Italy