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Prævalens af Fedme i MASLD (LeanMASLD)

3. november 2026 opdateret af: Amira Mohammed Abdel Mowgod, Assiut University

Forekomsten af Fedme i MASLD

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

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Asyut, Egypten
        • Assiut University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

  • 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

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: CASE_CONTROL
  • Tidsperspektiver: PROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of Obesity and Clinical Characteristics of Lean MASLD Patients
Tidsramme: 24 month

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

24 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Faktiske)

1. juli 2026

Studieafslutning (Faktiske)

1. juli 2026

Datoer for studieregistrering

Først indsendt

28. februar 2026

Først indsendt, der opfyldte QC-kriterier

28. februar 2026

Først opslået (Faktiske)

5. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 04-2026-300793

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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