NASH in Subjects With Different Classes of Obesity (CONNECT)

Prevalence of NASH in Subjects With Different Classes of Obesity

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; NAFLD; Obesity, Morbid; NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Procedure: Liver biopsy

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • University of Rome Sapienza
  • Rome, Italy, 00168
    • Catholic University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with different classes of obesity

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with obesity; Subjects with different classes of obesity	Procedure: Liver biopsy; Biopsy of the liver to assess for Non-alcoholic steatohepatitis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	6 months
Assessment of glycated hemoglobin	Assessment of glycated hemoglobin	6 months
Assessment of liver enzymes	Assessment of AST, ALT, GGT	6 months
Assessment of insulin	Assessment of fasting insulin	6 months
Assessment of metabolic profile	Assessment of HOMA-IR index	6 months

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Geltrude Mingrone, MD, PhD, Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): January 25, 2021
• Study Completion (Anticipated): January 25, 2023

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity, Morbid
• Other Study ID Numbers: 20202011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No