NCT04653103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

November 20, 2020

Last Update Submit

May 17, 2021

Conditions

NASH - Nonalcoholic SteatohepatitisNAFLDObesityObesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • Prevalence of NASH

    Prevalence of NASH in a cohort of patients with different classes of obesity

    6 months

Secondary Outcomes (6)

  • Assessment of lipid profile

    6 months

  • Assessment of glycemic profile

    6 months

  • Assessment of glycated hemoglobin

    6 months

  • Assessment of liver enzymes

    6 months

  • Assessment of insulin

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Patients with obesity

Subjects with different classes of obesity

Procedure: Liver biopsy

Interventions

Liver biopsyPROCEDURE

Biopsy of the liver to assess for Non-alcoholic steatohepatitis

Patients with obesity

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with different classes of obesity

You may qualify if:

  • Aged between 19 and 69 years

You may not qualify if:

  • Pregnancy
  • Active cancer
  • End stage renal failure
  • End stage liver failure
  • Being unable to understand and sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Rome Sapienza

Roma, Italy

Location

Catholic University School of Medicine

Rome, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityObesity, Morbid

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Geltrude Mingrone, MD, PhD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2020

First Posted

December 4, 2020

Study Start

November 20, 2020

Primary Completion

January 25, 2021

Study Completion

January 25, 2023

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)