Cohort of obese patients with nonalcoholic fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective cohort study focuses on obese individuals diagnosed with nonalcoholic fatty liver disease (NAFLD) through liver biopsy or MRI. It aims to investigate the factors that contribute to the progression from simple steatosis to nonalcoholic steatohepatitis (NASH) and to identify non-invasive diagnostic markers for NASH. Participants will complete various questionnaires and undergo multiple assessments, including blood and urine tests, fibroscan, and DEXA-scan, over a period of 5 to 10 years. The study will help in understanding the disease's progression and potential therapeutic options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (using MRI) or by histology.
* BMI ≥ 30 kg/m2
* Between 18 - 65 years of age

Exclusion Criteria:

* Incompetent to understand and/or sign the informed consent.
* Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
* Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female.
* Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker).
* Not willing to be informed about unexpected findings by MRI
* Unwilling to collect bio samples.
* Pregnancy and breastfeeding.
* Indication or planned for bariatric surgery within one year after inclusion or a history of bariatric surgery.
* Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
* Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.
* Individuals about to undergo or recovering from a surgical or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time

Where it's running

• Maastricht University Medical Center
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Study coordinator: Koek, MD, PhD
• Phone: 0031-43-3875021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining genetics, blood, urine, and stool data to predict complications of metabolic syndrome

  The team will try combining genetic, blood, urine, and stool data to see if patterns predict complications in adults with or without metabolic syndrome.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07248371

• ERCG (clip-and-loop endoscopic gastric reduction) versus optimized lifestyle for weight loss

  This trial will test whether ERCG, a sutureless endoscopic clip-and-loop procedure that reduces stomach volume, helps Chinese adults with BMI 24.0–37.4 kg/m² lose more weight than an optimized lifestyle program.

  Recruiting Beijing 302 Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07237750

• New MRI methods to measure metabolism and predict outcomes in metabolic-associated fatty liver disease

  This project tests whether new MRI techniques can measure body metabolism and help predict disease status and prognosis for people with metabolic-associated fatty liver disease.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07149571

• Low‑methoxy pectin for inflammation, gut microbiome, and metabolic health in MASLD

  This tests whether taking daily low‑methoxy pectin for six weeks can reduce inflammation and improve gut bacteria and metabolic markers in adults with MASLD.

  Recruiting at 3 sites University of Nottingham · Nottingham, United Kingdom and 2 other locations · NCT07093346

• Effects of Henagliflozein on liver fat in patients with diabetes and fatty liver disease

  This study is testing if a new diabetes medication called Henagliflozein can help reduce liver fat in people with type 2 diabetes and fatty liver disease.

  Recruiting Phase 4 Zhujiang Hospital · Guangzhou, Guangdong · NCT06449833

• Antiviral therapy for chronic hepatitis B with nonalcoholic fatty liver disease

  This study is testing if a new antiviral treatment can help people with chronic hepatitis B and fatty liver disease clear the virus better than the standard medication.

  Recruiting at 5 sites Phase 4 First Affiliated Hospital of Wenzhou Medical University · Ningbo and 4 other locations · NCT06368882

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.