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Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240145
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Gehad Abd Elaziz Mhmoud Ahmad, Assiut University

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

Condition or disease Intervention/treatment
NASH - Nonalcoholic Steatohepatitis Device: MSCT Abdomen

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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 30, 2021



Intervention Details:
  • Device: MSCT Abdomen
    Visceral fat volumetry using MSCT and it's relation to NASH


Primary Outcome Measures :
  1. NasH in relation to visceral and subcutaneous fat [ Time Frame: base line ]
    Visceral fat volumetryusing MSCT and it'srelation tovisceral andsubcutaneous fat



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240145


Contacts
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Contact: Gehad Abd Elaziz Mhmoud 01005304239 gehadabdelazia@yahoo.com

Sponsors and Collaborators
Gehad Abd Elaziz Mhmoud Ahmad
Investigators
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Principal Investigator: Assiut University Assiut University
Publications:
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Responsible Party: Gehad Abd Elaziz Mhmoud Ahmad, Assiut Universityhospital, Assiut University
ClinicalTrials.gov Identifier: NCT04240145    
Other Study ID Numbers: NASH
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases