- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04240145
Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NasH in relation to visceral and subcutaneous fat
Time Frame: base line
|
Visceral fat volumetryusing MSCT and it'srelation tovisceral andsubcutaneous fat
|
base line
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Assiut University, Assiut University
Publications and helpful links
General Publications
- Angulo P. Nonalcoholic fatty liver disease. N Engl J Med. 2002 Apr 18;346(16):1221-31. doi: 10.1056/NEJMra011775. No abstract available.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NASH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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