Clinical trial NCT04240145: Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat
Official title: Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient from age 18 to 75 years of both gender presented to Assiut University hospital with raised liver enzymes

Brief summary: Evaluate the relationship between the severity of fatty liver in NAFLD assessed by ultrasonography and CT and the visceral fat area measured by CT

Detailed description: Non alcoholic fatty liver disease is one of the most common causes of chronic liver disease world wide . Severe forms of NAFLD such as nonalcoholic steatohepatitis can progress to end-stage liver disease such as cirrhosis or hepatocellular carcinoma. Therefore, investigating risk factors associated with hepatic steatosis is required to perform effective screening .

Hepatic steatosis develops for a variety reasons but obesity is the most common associated condition.

Obesity is considered a gateway disease and NAFLD is considered to be one of the phenotypes of metabolic syndrome, which is characterized by obesity with visceral fat accumulation, diabetes, hypertension and dyslipidemia.

Individuals with severe obesity have a disproportionately high risk of comorbidities including nonalcoholic fatty liver disease (NAFLD), cardiovascular disease and diabetes.

The distribution of fat appears more important than the total fat mass in obesity .A predominantly upper body fat distribution increases the risks for the metabolic complications of obesity including hepatic steatosis especially when it is associated with increased intra abdominal fat .

Most "metabolically obese" normal weight subjects have some increase in adipose tissue mass and insulin resistance probably due to an increase in visceral fat. Thus, subjects with a relatively low BMI can have gross increases in abdominal visceral fat, and others with a high BMI may have very little intra abdominal/visceral fat .

Several studies suggested visceral adiposity to be a clinical predictor of hepatic steatosis .

In addition, the severity of fatty liver has been linked to the VAT area as evaluated by CT.

Eligibility criteria: Inclusion Criteria:

* patient aged from 18years to 75years of both gender presented to Alrajhi hospital with raised liver enzymes in period from October 2019 to June 2020

Exclusion Criteria:

* patient with viral hepatitis History of drug intake Auto immune hepatitis

Primary outcomes:
measure: NasH in relation to visceral and subcutaneous fat
timeFrame: base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Assiut University
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kershaw EE, Flier JS. Adipose tissue as an endocrine organ. J Clin Endocrinol Metab. 2004 Jun;89(6):2548-56. doi: 10.1210/jc.2004-0395.
citation: Angulo P. Nonalcoholic fatty liver disease. N Engl J Med. 2002 Apr 18;346(16):1221-31. doi: 10.1056/NEJMra011775. No abstract available.
citation: Ong JP, Pitts A, Younossi ZM. Increased overall mortality and liver-related mortality in non-alcoholic fatty liver disease. J Hepatol. 2008 Oct;49(4):608-12. doi: 10.1016/j.jhep.2008.06.018. Epub 2008 Jul 9.