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

NCT04946786 | Unknown

• 1 other identifier: Soh-Med-21-06-13
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-alcoholic Fatty Liver Disease NAFLD

Keywords

Non-alcoholic fatty liver disease NAFLD

Outcome Measures

Primary Outcomes (8)

• 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.

Interventions

Laboratory investigations, pelvi-abdominal US, fibroscan, and in body analysis DIAGNOSTIC_TEST

1. Complete history taking. 2. Thorough clinical examination :Assessing for buffalo hump, double chin, acanthosis nigricans, skin tags or acrochordon and xanthelasma and anthropometric measurements as measuring height "m", weight "Kg", waist circumference (WC) "Cm", hip circumference (HC) "Cm". 3\. Pelvi-abdominal ultrasound. 4. Fibroscan examination will be done for all subjects to assess steatosis by measuring the CAP score. 5\. Body composition analysis: to detect water, muscle and fat percentage in the body. 6\. Laboratory investigations:All samples wil be analyzed for fasting blood glucose (FBG), and post-prandial (2hrs after meals) blood glucose, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein (VLDL-C), alkaline phosphatase (ALK), aspartate transaminase (AST),alanine transaminase (ALT). • Fasting insulin levels will be measured using ELISA kits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (3)

• 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.

  PMID: 27358840 BACKGROUND

• 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.

  PMID: 25492997 BACKGROUND

• 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.

  PMID: 20067971 BACKGROUND

Central Study Contacts

Wafaa G Mohamed, Master

CONTACT

01111390732; wafaa_gamal_post@med.sohag.edu.eg

Ghada M Kamal, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: priciple investigator

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: July 1, 2021
• Study Start: July 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share