NASH - Nonalcoholic SteatohepatitisNCT04240145
Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat
An observational study of NASH - Nonalcoholic Steatohepatitis, run by Gehad Abd Elaziz Mhmoud Ahmad.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- MSCT Abdomen
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patient from age 18 to 75 years of both gender presented to Assiut University hospital with raised liver enzymes
Who may be able to join
- 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
Who cannot join
- patient with viral hepatitis History of drug intake Auto immune hepatitis
Trial locations and contacts
No sites are listed yet.
About this study
Evaluate the relationship between the severity of fatty liver in NAFLD assessed by ultrasonography and CT and the visceral fat area measured by CT
Read the 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.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- MSCT Abdomen
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCT AbdomenDevice
Visceral fat volumetry using MSCT and it's relation to NASH
What is being measured
The primary outcome is the main question the study is designed to answer.
NasH in relation to visceral and subcutaneous fat
Visceral fat volumetryusing MSCT and it'srelation tovisceral andsubcutaneous fat
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gehad Abd Elaziz Mhmoud Ahmad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gehad Abd Elaziz Mhmoud Ahmad, Assiut University
- Investigators
- Assiut University, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240145
- Sponsor's protocol ID
- NASH
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15181022Angulo P. Nonalcoholic fatty liver disease. N Engl J Med. 2002 Apr 18;346(16):1221-31. doi: 10.1056/NEJMra011775. No abstract available.
PubMed 11961152Ong 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.
PubMed 18682312
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat
- ClinicalTrials.gov ID
- NCT04240145
- Acronym / sponsor ID
- NASH
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Gehad Abd Elaziz Mhmoud AhmadUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient from age 18 to 75 years of both gender presented to Assiut University hospital with raised liver enzymes
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patient with viral hepatitis History of drug intake Auto immune hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCT AbdomenVisceral fat volumetry using MSCT and it's relation to NASH | Device | – |
Primary outcome
NasH in relation to visceral and subcutaneous fat
Time frame: base line
Visceral fat volumetryusing MSCT and it'srelation tovisceral andsubcutaneous fat
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 15181022Kershaw 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.
- Background: PubMed 11961152Angulo P. Nonalcoholic fatty liver disease. N Engl J Med. 2002 Apr 18;346(16):1221-31. doi: 10.1056/NEJMra011775. No abstract available.
- Background: PubMed 18682312Ong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assiut University principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of NASH - Nonalcoholic Steatohepatitis, run by Gehad Abd Elaziz Mhmoud Ahmad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gehad Abd Elaziz Mhmoud (01005304239, gehadabdelazia@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NasH in relation to visceral and subcutaneous fat (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240145, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.