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

NCT ID: NCT04946786

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-07-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Wafaa Gamal Mohamed

priciple investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wafaa G Mohamed, Master

Role: CONTACT

wafaa_gamal_post@med.sohag.edu.eg

01111390732

Ghada M Kamal, Professor

Role: CONTACT

References

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.

Reference Type: BACKGROUND

PMID: 27358840 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25492997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20067971 (View on PubMed)

Other Identifiers

Soh-Med-21-06-13

Identifier Type: -

Identifier Source: org_study_id