NASH in Subjects With Different Classes of Obesity | NCT04653103

Studies
NASH in Subjects With Different Classes of Obesity

NCT04653103

Sponsor

Catholic University of the Sacred Heart

Status

Unknown status

Last Update Posted

May 18, 2021Actual

Enrollment

500Actual

Phase

Not provided

Conditions

NASH - Nonalcoholic Steatohepatitis
NAFLD
Obesity
Obesity, Morbid

Interventions

Liver biopsy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2020Actual

Primary Completion Date

Jan 25, 2021Actual

Completion Date

Jan 25, 2023Estimated

First Submitted Date

Nov 20, 2020

First Submission Date that Met QC Criteria

Nov 26, 2020

First Posted Date

Dec 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2021

Last Update Posted Date

May 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Geltrude Mingrone, Professor, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with obesity		Subjects with different classes of obesity	Procedure: Liver biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver biopsy	Procedure	Biopsy of the liver to assess for Non-alcoholic steatohepatitis	Patients with obesity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of NASH	Prevalence of NASH in a cohort of patients with different classes of obesity	6 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of lipid profile	Assessment of triglycerides, total cholesterol, LDL and HDL cholesterol	6 months
Assessment of glycemic profile	Assessment of fasting glucose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with different classes of obesity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geltrude Mingrone, MD, PhD	Catholic University of the Sacred Heart	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rome Sapienza		Roma			Italy
Catholic University School of Medicine

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D009765	Obesity
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D050177	Overweight

Browse Leaves

Not provided

Browse Branches

Not provided