NASH in Subjects With Different Classes of Obesity

Obesity Clinical Trial

— CONNECT  

Official title:

Prevalence of NASH in Subjects With Different Classes of Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04653103
• Other study ID #: 20202011
• Status: Active, not recruiting
• Start date: November 20, 2020
• Est. completion date: January 25, 2023

Study information

• Verified date: May 2021
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NAFLD
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Liver biopsy
Biopsy of the liver to assess for Non-alcoholic steatohepatitis

Locations

Country	Name	City	State
Italy	University of Rome Sapienza	Roma
Italy	Catholic University School of Medicine	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of NASH	Prevalence of NASH in a cohort of patients with different classes of obesity	6 months
Secondary	Assessment of lipid profile	Assessment of triglycerides, total cholesterol, LDL and HDL cholesterol	6 months
Secondary	Assessment of glycemic profile	Assessment of fasting glucose	6 months
Secondary	Assessment of glycated hemoglobin	Assessment of glycated hemoglobin	6 months
Secondary	Assessment of liver enzymes	Assessment of AST, ALT, GGT	6 months
Secondary	Assessment of insulin	Assessment of fasting insulin	6 months
Secondary	Assessment of metabolic profile	Assessment of HOMA-IR index	6 months