An observational study in MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational
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).
Metabolic dysfunction associated liver disease (MASLD) is a significant public health concern worldwide with a complex etiology attributed to behavioural, environmental, and genetic causes. The worldwide prevalence of MASLD is estimated to be 32.4% and constantly rising.
Several studies suggest differences in the prevalence and severity of MASLD by race or ethnicity, which may be linked to differences in lifestyle, diet, metabolic comorbidity profile, and genetic background, among others.
Race/ethnicity research is essential as it can provide valuable information regarding biological and genetic differences among people with similar cultural, dietary, and geographical backgrounds.
There is ample epidemiological evidence on the role of genetic susceptibility in MASLD, mainly from studies showing the clustering of MASLD cases among families and observing differences in the prevalence and severity of MASLD among ethnicities.
The Overseas territories population is predominantly of African descent due to slave trade of population from sub-Saharan Africa between the seventeenth and nineteenth centuries. They have also been a mixture from Europeans and Indians. Indian are descents from Latin America, initially present on the territories, and from Asia, after the abolition of slavery. Data about MASLD in Overseas territories are scarce. To our knowledge, one study reported the prevalence of MASLD in Caribbean and Hispanic populations resident in the United States compared with Hispanic residents in Latin America (Kallwitz 2015). In the later study, rates of MASLD were significantly lower in persons with Caribbean origin than those of Latin America heritage.
Genetic susceptibility variations may partially explain the heterogeneity observed in the MASLD prevalence/incidence estimates from different geographical regions and the variability in disease severity among individuals. Genetic factors have been suggested as one of the underlying causes of racial/ethnic differences in susceptibility to MASLD.
Among the building blocks of metabolic syndrome, type 2 diabetes and obesity have been significantly associated with an increased risk of MASH with more severe progression to cirrhosis or liver cancer.
However, in overseas, the prevalence of type 2 diabetes (10%), high blood pressure (28%), or obesity (30%) are among the highest in France.
PNPLA3 expression is implicated in intrahepatic lipid accumulation and is associated with lipotoxicity and the more severe phenotypes, including fibrosis and carcinogenesis. Therefore, in this study, PNPLA3 polymorphisms will be analysed to evaluate the profile of MASLD patients in overseas territories. A biological sample will be taken to analyse PNPLA3 polymorphisms in DROMSteatExpo study.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's planned enrollment of 600 is above the median of 150 across 206 observational studies indexed under Fatty Liver.
Browse Fatty Liver studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
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Prospective longitudinal multicentric study
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.
Exclusion Criteria:
Viral hepatitis (B, C, or E)
Primary biliary cholangitis or primary sclerosing cholangitis
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allele frequencies of PNPLA3 variants
The primary outcome is the allele frequencies of PNPLA3 gene variants in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) from the overseas population. Genotyping will be performed on DNA extracted from patient blood samples, and the frequency of each allele will be reported as the proportion of participants carrying the variant.
Time frame: Baseline (inclusion visit).
Distribution of MASLD Clinical Stages at Baseline
The distribution of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) clinical stages at baseline will be assessed by physician clinical evaluation. Participants will be classified into clinical categories including simple steatosis and non-alcoholic steatohepatitis (NASH). The outcome will be reported as the number and percentage of participants in each clinical stage.
Time frame: Baseline (inclusion visit).
Distribution of Liver Fibrosis Stages Assessed by Imaging at Baseline
Liver fibrosis stage will be assessed at baseline using imaging-based liver stiffness measurements (e.g., transient elastography, magnetic resonance elastography, or MRI-based techniques, as available at participating centers). Fibrosis stages will be categorized according to standard fibrosis stages (F0-F4). The outcome will be reported as the number and percentage of participants in each fibrosis stage.
Time frame: Baseline (inclusion visit).
Distribution of MASLD Severity Based on Laboratory Biomarkers at Baseline
MASLD severity will be assessed at baseline using laboratory biomarkers, including liver enzymes (e.g., ALT, AST) and metabolic parameters. Results will be categorized according to predefined clinical thresholds. The outcome will be reported as the number and percentage of participants within each severity category.
Time frame: Baseline (inclusion visit).
Plan to share: Undecided
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Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 24 months after the start.
Of 87 non-industry observational studies under Fatty Liver, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 68. This study's planned 24 months is below that.
Counting every sponsor, half of 96 studies reached it within 33 months; a quarter within 20 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Universitaire de la Guadeloupe