Study of PNPLA3 Genetic Polymorphisms in Patients With Non-Alcoholic Fatty Liver Disease in an Ultramarine Population (AdipoDROMExpo)
Recruiting · NCT07330830 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
View the official record on ClinicalTrials.gov →What this trial is about
Metabolic Dysfunction Associated Liver Disease (MASLD) is associated with metabolic syndrome, and PNPLA3 variants are known to be implicated in intrahepatic lipid accumulation and linked to lipotoxicity. Analysis of PNPLA3 polymorphisms in an overseas territories population of MASLD would be interesting to describe their profile susceptibility to develop Metabolic dysfunction associated steatohepatitis (MASH).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Adult patients (≥18 years old) seen in consultation or hospitalized in the Hepato-Gastroenterology Departments of the University Hospitals of Guadeloupe, French Guiana, and Réunion Island, with a diagnosis of MASLD.
- MASLD is defined as evidence of hepatic steatosis associated with overweight/obesity, type 2 diabetes, or metabolic syndrome according to ATP III (2005) criteria.
- Patients affiliated with, or beneficiaries of, a social security scheme.
- Free, informed, and written consent obtained from the participant and signed by both the participant and the investigator (no later than the day of inclusion and prior to any procedure required by the study).
Exclusion criteria
- Patients under 18 years of age.
- Patients unable to provide informed consent; so-called vulnerable populations (individuals under guardianship, judicial protection, etc.).
- Presence of another cause of chronic liver disease, including:
- Viral hepatitis (B, C, or E)
- Primary biliary cholangitis or primary sclerosing cholangitis
- Autoimmune hepatitis
- Wilson's disease
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Alcoholic liver disease, or daily alcohol consumption \>30 g/day for men or \>20 g/day for women
- Pregnant women.
Where it is running
3 locations listed.
- Centre Hospitalier Universitaire de la Guyane - Cayenne, French Guiana
- CHU de la Guadeloupe - Pointe-à-Pitre, Guadeloupe
- Centre Hospitalier Universitaire de la Réunion - Saint-Denis, Reunion