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Non-alcoholic Fatty Liver Disease NAFLDNCT04946786

Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Non Alcoholic Fatty Liver Disease

An observational study of Non-alcoholic Fatty Liver Disease NAFLD, run by Sohag University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-alcoholic Fatty Liver Disease NAFLD
What is being tested?
Laboratory investigations, pelvi-abdominal US, fibroscan, and in body analysis
How many people
80 participants
Where
No sites listed yet
Study dates
1 Jul 2021to 31 Jul 2023
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 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • Adult subjects with bright liver by abdominal ultrasound will be recruited.
  • The diagnosis will be based on CAP score result measured by Fibroscan.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Wafaa G Mohamed, Master contact

01111390732

wafaa_gamal_post@med.sohag.edu.eg

Ghada M Kamal, Professor contact

About this study

Official title: Role of Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Patients With Non Alcoholic Fatty Liver Disease

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).

Read more

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.

Being tested
Laboratory investigations, pelvi-abdominal US, fibroscan, and in body analysis
Keywords
Non-alcoholic fatty liver disease NAFLD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory investigations, pelvi-abdominal US, fibroscan, and in body analysisDiagnostic test

    1. Complete history taking.
    2. Thorough clinical examination :Assessing for buffalo hump, double chin, acanthosis nigricans, skin tags or acrochordon and xanthelasma and anthropometric measurements as measuring height "m", weight "Kg", waist circumference (WC) "Cm", hip circumference (HC) "Cm".
    3. Pelvi-abdominal ultrasound. 4. Fibroscan examination will be done for all subjects to assess steatosis by measuring the CAP score.
    4. Body composition analysis: to detect water, muscle and fat percentage in the body.
    5. Laboratory investigations:All samples wil be analyzed for fasting blood glucose (FBG), and post-prandial (2hrs after meals) blood glucose, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein (VLDL-C), alkaline phosphatase (ALK), aspartate transaminase (AST),alanine transaminase (ALT).
    • Fasting insulin levels will be measured using ELISA kits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. studying anthropometric measurements of NAFLD cases.

    -study anthropometric measurements.

    Measured: 2 years

  2. measurement of steatosis by fibroscan examination

    Fibroscan examination measuring control attenuation parameter "CAP score"

    Measured: 2 years

  3. body muscle percentage

    measurement of body muscle percentage

    Measured: 2 years

  4. body fat percentage.

    measurement of body fat percentage

    Measured: 2 years

  5. measurement of body water percentage.

    measurement of body water percentage.

    Measured: 2 years

  6. measuring serum cholesterol

    measuring serum cholesterol by mg/ dl.

    Measured: 2 years.

  7. measuring serum triglycerides.

    measuring serum triglycerides by mg/ dl.

    Measured: 2 years.

  8. measuring serum insulin level.

    measuring of serum insulin level using ELISA kits

    Measured: 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion31 Jul 2023 (estimated)
  4. Study completion31 Jul 2023 (estimated)

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04946786
Sponsor's protocol ID
Soh-Med-21-06-13
Status last verified
Jun 2021
First submitted
13 Jun 2021
Last updated
1 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 27358840

  • 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.

    PubMed 25492997

  • 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.

    PubMed 20067971

Questions about this trial

What is this clinical trial studying?

An observational study of Non-alcoholic Fatty Liver Disease NAFLD, run by Sohag University.

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 2 inclusion and 6 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 1 Jul 2021. 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 Wafaa G Mohamed, Master (01111390732, wafaa_gamal_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

studying anthropometric measurements of NAFLD cases. (time frame: 2 years). The study lists 8 primary outcomes in all. 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 NCT04946786, 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 1 Jul 2021.

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