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NCT04653103 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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