Clinical trial NCT04946786: Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Non Alcoholic Fatty Liver Disease
Official title: Role of Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Patients With Non Alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease NAFLD
Keywords: Non-alcoholic fatty liver disease NAFLD
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: studying anthropometric measurements of NAFLD cases.
timeFrame: 2 years
measure: measurement of steatosis by fibroscan examination
timeFrame: 2 years
measure: body muscle percentage
timeFrame: 2 years
measure: body fat percentage.
timeFrame: 2 years
measure: measurement of body water percentage.
timeFrame: 2 years
measure: measuring serum cholesterol
timeFrame: 2 years.
measure: measuring serum triglycerides.
timeFrame: 2 years.
measure: measuring serum insulin level.
timeFrame: 2 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.