- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04946786
Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Non Alcoholic Fatty Liver Disease
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).
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Wafaa G Mohamed, Master
- Telefonnummer: 01111390732
- E-post: wafaa_gamal_post@med.sohag.edu.eg
Studer Kontakt Backup
- Navn: Ghada M Kamal, Professor
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
Inclusion criteria:
- Adult subjects with bright liver by abdominal ultrasound will be recruited.
- The diagnosis will be based on CAP score result measured by Fibroscan.
Exclusion criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
studying anthropometric measurements of NAFLD cases.
Tidsramme: 2 years
|
-study anthropometric measurements.
|
2 years
|
|
measurement of steatosis by fibroscan examination
Tidsramme: 2 years
|
Fibroscan examination measuring control attenuation parameter "CAP score"
|
2 years
|
|
body muscle percentage
Tidsramme: 2 years
|
measurement of body muscle percentage
|
2 years
|
|
body fat percentage.
Tidsramme: 2 years
|
measurement of body fat percentage
|
2 years
|
|
measurement of body water percentage.
Tidsramme: 2 years
|
measurement of body water percentage.
|
2 years
|
|
measuring serum cholesterol
Tidsramme: 2 years.
|
measuring serum cholesterol by mg/ dl.
|
2 years.
|
|
measuring serum triglycerides.
Tidsramme: 2 years.
|
measuring serum triglycerides by mg/ dl.
|
2 years.
|
|
measuring serum insulin level.
Tidsramme: 2 years.
|
measuring of serum insulin level using ELISA kits
|
2 years.
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Soh-Med-21-06-13
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