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Lean MASLDLeanMASLDNCT07451366

Prevalence of Obesity in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

An observational study of Lean MASLD, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our study will assess the prevalence of obesity among patients with (MASLD) and to evaluate the characteristics of lean MAFLD patients. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Lean MASLD
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Jul 2026to 1 Jul 2026
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: * After obtaining the appropriate consents, data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake). * Imaging techniques, such as ultrasonography (US), fibroscan with CAP and/or computed topography (CT) and /or MRI. * Blood samples will be collected for CBC. ( Hb level , WBCs, Platelets), liver function tests (albumin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase, total bilirubin), lipid profile (total cholesterol, triglyceride, LDL), CRP, serum uric acid, HbA1c, and Kidney function test(serum urea and creatinine). * Six measurements will be obtained (sex, age, height, weight, body mass index, and waist circumference

Who may be able to join

  • All patients aged >18 years old
  • diagnosed as fatty liver based on clinical examination, laboratory investigations and imaging techniques

Who cannot join

  • Patients aged ≤18 years old.
  • Pregnancy.
  • Presence of malignancy
  • Type I DM.
  • Fatty liver patients on treatment by statin derivatives or other medications.
  • Fatty liver patients undergone bariatric surgerie

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University

    Asyut

Other trials in Egypt

About this study

Our study will assess the prevalence of obesity among patients with (MASLD) and to evaluate the characteristics of lean MAFLD patients.

Read the detailed description

Non-alcoholic fatty liver disease (NAFLD) has become more common in recent years. NAFLD is thought to be the primary cause of chronic liver disorders, and it has grown to be a significant global public health concern.

The prevalence of NAFLD has been steadily rising due to changes in lifestyle and dietary patterns, making it the most common chronic liver ailment globally.

The global prevalence of NAFLD is 30.1%. Recently published an international expert consensus statement about a new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) to replace non-alcoholic fatty liver disease (NAFLD).

The new nomenclature of MAFLD is based on the presence of steatosis in >5% of hepatocytes and the absence of excessive alcohol consumption or other causes of chronic liver disease, diagnosis of MAFLD could be established on the presence of hepatic steatosis in combination with one of the following three criteria: overweight/obesity; presence of type 2 diabetes mellitus; or evidence of metabolic dysregulation.

Metabolic dysregulation is defined as having at least 2 of the following metabolic risk abnormalities: high waist circumference, high blood pressure, high cholesterol, pre-diabetes, insulin resistance, and high plasma C-reactive protein levels.

In 2023, a new name, metabolic dysfunction-associated steatotic liver disease (MASLD). At the same time, experts introduced the broad umbrella term steatotic liver disease (SLD) to encompass both metabolic- and alcohol-based fatty liver disease. As an umbrella term, SLD allows for a continuum of alcohol ingestion to more adequately quantify its role in the progression of liver disease.

Irrespective of the nomenclature, MASLD is recognized as the most common cause of chronic liver disease (CLD), with the most recent meta-analysis suggesting that more than 38% of the world's adult population and between 7% and 14% of children are affected. Although the burden of MASLD is increasing around the world, in the many countries where viral hepatitis remains endemic, resources and efforts to treat and reduce that disease must continue to be prioritized.

Although NAFLD is observed predominantly in persons with obesity and/or type 2 diabetes mellitus (T2DM), an estimated 7%-20% oindividuals with NAFLD have leanbody habitus.

Lean NAFLD is generally defined by the presence of NAFLD in an individual who does not have an overweight or obese BMI. For adults, the Centers for Disease Control and Prevention and the World Health Organization define a normal range BMI to be between 18.5 and 24.9 kg/m2; BMI of 25-29.9 kg/m2 is considered overweight and BMI of 30- 34.9 kg/m2 is grade 1 obesity.

The World Health Organization recommends a lower BMI cutoff for overweight and obesity (BMI 23-27.5 kg/m2 for overweight and BMI >27.5 kg/m2 for obesity) for those of Asian ancestry, recognizing that different populations may experience metabolic risk at a lower BMI. We suggest using the term lean NAFLD when discussing NAFLD in the setting of a normal range BMI.

Conditions
Lean MASLD

What is being measured

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

  1. Prevalence of Obesity and Clinical Characteristics of Lean MASLD Patients

    This study aims to assess the prevalence of obesity among patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and to evaluate the demographic, clinical, and metabolic characteristics of lean MASLD patients

    Measured: 24 month

Timeline

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

  1. First posted5 Mar 2026
  2. Study start1 Jul 2026
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

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
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451366
Sponsor's protocol ID
04-2026-300793
Acronym
LeanMASLD
Status last verified
Dec 2025
First submitted
28 Feb 2026
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lean MASLD, run by Assiut University at 1 site in Egypt.

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: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Obesity and Clinical Characteristics of Lean MASLD Patients (time frame: 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Nov 2026.

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