NASH in Subjects With Different Classes of Obesity

NCT ID: NCT04653103

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2023-01-25

Brief Summary

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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

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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.

Conditions

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NASH - Nonalcoholic Steatohepatitis NAFLD Obesity Obesity, Morbid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with obesity

Subjects with different classes of obesity

Liver biopsy

Intervention Type PROCEDURE

Biopsy of the liver to assess for Non-alcoholic steatohepatitis

Interventions

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Liver biopsy

Biopsy of the liver to assess for Non-alcoholic steatohepatitis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Geltrude Mingrone

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geltrude Mingrone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

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University of Rome Sapienza

Roma, , Italy

Site Status

Catholic University School of Medicine

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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20202011

Identifier Type: -

Identifier Source: org_study_id

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