Treatment for Non-Alcoholic Fatty Liver Disease in Primary Care
Identification and Characterization of Non-alcoholic Fatty Liver Disease in Primary Care
This study is testing if a special imaging tool called FibroScan can help doctors in primary care better diagnose and manage Non-Alcoholic Fatty Liver Disease in adults who are overweight or have related health issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1470 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Maastricht University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT04918732 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and associated conditions such as obesity, type 2 diabetes, and cardiovascular diseases. It aims to assess the effectiveness of FibroScan, a non-invasive imaging technique, in diagnosing and managing NAFLD in a primary care setting. The study will include participants who meet specific eligibility criteria, including being between 18-80 years old and having a BMI greater than 25 kg/m². The goal is to improve early detection and management of NAFLD to prevent progression to more severe liver diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 with a BMI over 25 kg/m² and conditions such as obesity, type 2 diabetes, or cardiovascular diseases.
Not a fit: Patients with excessive alcohol use, other liver diseases, or secondary causes for steatosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management and treatment options for patients with NAFLD and related metabolic conditions.
How similar studies have performed: Other studies have shown promise in using non-invasive techniques like FibroScan for diagnosing liver conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to understand and sign the informed consent * Able to speak Dutch * Between 18-80 years * BMI \>25 kg/m² * Having one of the following conditions: 1)overweight, 2) obesity, 3) type 2 diabetes mellitus, 4) cardiovascular diseases (hypertension, atherosclerosis, angina pectoris, ischaemic heart condition, cerebrovascular condition) Exclusion Criteria: * Excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 glasses alcohol/day for women and \>3 glasses for men) * Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency * Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART), lean steatosis, Celiac disease, environmental toxicity * Pregnancy and breastfeeding. * 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 a surgery 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 (e.g., after 3 months are myocardial infarction patients are eligible for participation).
Where this trial is running
Maastricht, Limburg
- Maastricht University — Maastricht, Limburg, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.