Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Non Alcoholic Fatty Liver Disease

Role of Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Patients With Non Alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) includes a spectrum of liver disorders characterized by accumulation of hepatic fat in absence of significant alcohol consumption (<20 gm/day) and other causes of liver diseases. It is the most common cause of asymptomatic elevation of liver enzymes worldwide (Marchesini et al., 2003).

Unfortunately, to date, existing non- or minimally invasive biomarkers are inadequate. While a number of non- or minimally invasive tests are able to rule out fibrosis or cirrhosis, no single test to identify steatosis, to early diagnose NASH, or to predict the disease progression is available. Moreover, specialized, combined tests are required to assess treatment response in clinical trials on emerging compounds (Piazzolla and Mangia, 2020).

Among minimally invasive tools, plasma biomarkers and composite scores defined as "wet biomarkers" are commonly used. For example, fasting insulin level and its use in measurement of insulin resistance, Lipid Accumulation Product (LAP) score (Bedogni et al., 2010), the NAFLD Liver Fat Score (NLFS) (Kontronen et al., 2009), Hepatic Steatosis Index (HSI) (Lee et al., 2010), controlled attenuation parameter (CAP) measurement by fibroscan (Piazzolla and Mangia, 2020). Recent studies have shown that CAP significantly correlates with the percentage of steatosis and steatosis grade and that median CAP is higher among patients with significant steatosis (Sasso et al., 2012 & Karlas et al., 2017).

The prevalence of NAFLD is 80-90% in obese, 30-50% in patients with diabetes and up to 90% in patients with hyperlipidemia (Abenavoli et al., 2014)

Central obesity or visceral fat (VF) (determined by waist circumference (WC)) is defined as the presence of excess fat in the abdomen, and this type of obesity is often associated with the development and progression of NAFLD or more advanced forms of liver disease (Abenavoli et al., 2016). Thus, measurement of body composition rather than BMI may be helpful in the prediction of NAFLD (Milić et al., 2014 and Abenavoli et al., 2016)

There is a growing need to assess the steatosis in NAFLD patients using minimally invasive tools.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-alcoholic Fatty Liver Disease NAFLD
• Intervention / Treatment: Diagnostic test: Laboratory investigations, pelvi-abdominal US, fibroscan, and in body analysis

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Wafaa G Mohamed, Master; Phone Number: 01111390732; Email: wafaa_gamal_post@med.sohag.edu.eg
• Study Contact Backup: Name: Ghada M Kamal, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients: A total of 80 adult subjects will be included.

Inclusion criteria:

Adult subjects with bright liver by abdominal ultrasound will be recruited for the study. The diagnosis will be based on CAP score result measured by Fibroscan.

Description

Inclusion criteria:

• Adult subjects with bright liver by abdominal ultrasound will be recruited.
• The diagnosis will be based on CAP score result measured by Fibroscan.

Exclusion criteria:

• Alcohol consumption.
• Patients with other liver diseases as acute and chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, drug-induced hepatitis.
• Decompensated liver disease.
• Other end organ failure.
• Pregnancy.
• Patients on statins or fenofibrate.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
studying anthropometric measurements of NAFLD cases.	-study anthropometric measurements.	2 years
measurement of steatosis by fibroscan examination	Fibroscan examination measuring control attenuation parameter "CAP score"	2 years
body muscle percentage	measurement of body muscle percentage	2 years
body fat percentage.	measurement of body fat percentage	2 years
measurement of body water percentage.	measurement of body water percentage.	2 years
measuring serum cholesterol	measuring serum cholesterol by mg/ dl.	2 years.
measuring serum triglycerides.	measuring serum triglycerides by mg/ dl.	2 years.
measuring serum insulin level.	measuring of serum insulin level using ELISA kits	2 years.

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Abenavoli L, Di Renzo L, De Lorenzo A. Body Composition and Non-alcoholic Fatty Liver Disease. J Lifestyle Med. 2016 Mar;6(1):47-8. doi: 10.15280/jlm.2016.6.1.47. Epub 2016 Mar 31. No abstract available.
• Abenavoli L, Milic N, Peta V, Alfieri F, De Lorenzo A, Bellentani S. Alimentary regimen in non-alcoholic fatty liver disease: Mediterranean diet. World J Gastroenterol. 2014 Dec 7;20(45):16831-40. doi: 10.3748/wjg.v20.i45.16831.
• Amato MC, Giordano C, Galia M, Criscimanna A, Vitabile S, Midiri M, Galluzzo A; AlkaMeSy Study Group. Visceral Adiposity Index: a reliable indicator of visceral fat function associated with cardiometabolic risk. Diabetes Care. 2010 Apr;33(4):920-2. doi: 10.2337/dc09-1825. Epub 2010 Jan 12.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Non-alcoholic fatty liver disease NAFLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Soh-Med-21-06-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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