NCT07330830 Study of PNPLA3 Genetic Polymorphisms in Patients With Non-Alcoholic Fatty Liver Disease in an Ultramarine Population (AdipoDROMExpo)
| NCT ID | NCT07330830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de la Guadeloupe |
| Condition | MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2027-11-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-11-26 with a primary completion date of 2027-11-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
IInclusion 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.
Contact & Investigator
Moana Gelu-Simeon, MD PhD
STUDY CHAIR
CHU de la Guadeloupe
Frequently Asked Questions
Who can join the NCT07330830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07330830 currently recruiting?
Yes, NCT07330830 is actively recruiting participants. Contact the research team at melanie.petapermal@chu-guadeloupe.fr for enrollment information.
Where is the NCT07330830 trial being conducted?
This trial is being conducted at Cayenne, French Guiana, Pointe-à-Pitre, Guadeloupe, Saint-Denis, Reunion.
Who is sponsoring the NCT07330830 clinical trial?
NCT07330830 is sponsored by Centre Hospitalier Universitaire de la Guadeloupe. The principal investigator is Moana Gelu-Simeon, MD PhD at CHU de la Guadeloupe. The trial plans to enroll 600 participants.