NCT06647095Completed
New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
Identification of New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Patients by Blood Plasma Spectroscopy, Breath Volatile Organic Compounds Analysis and Serum Bile Acids Analysis
Source: ClinicalTrials.gov · Last updated 1 Nov 2024
Brief summary (registry, in English)
The goal of this observational study is to learn if some components of blood or exhaled breath can diagnose people having more fat in their livers than is normal, because of their poorer metabolic health (for example, because of obesity and diabetes). The main questions it aims to answer are: 1. Can a method find participants with higher liver fat than healthy participants? 2. Can a method find participants in whom higher liver fat was a cause of liver inflammation or stiffness? Participants will: * fast overnight * have a routine blood draw * easily exhale a few times into a special device or a plastic bag and fill in a short dietary questionnaire (if participating in a breath test) * optionally swallow capsules with an orange peel extract and fish oil before exhaling, which can help get better results from breath (capsules will be medically safe and approved)
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 172 (actual)
- First submitted
- 15 Oct 2024
- Start date
- 1 Sept 2021
- Primary completion date
- 1 Sept 2022
- Lead sponsor
- General University Hospital, Prague
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06647095
What you commit to
- Study type: Observational
- Participants enrolled: 172
- From 1 Sept 2021 to the primary completion date, 1 Sept 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For bile acid analysis: Treatment with BA or BA sequestrants
Other illness
- Failure to sign the informed consent form
- For LMN a TMA "stress test": fish, see fruit and citrus fruit allergy
- For bile acid analysis: Portal hypertension (does not apply for MASH patients)
Other
- Non-compliance with the investigation program
- Liver biopsy/clinic discrepancy
- Pregnancy
- For bile acid analysis: Cirrhosis (does not apply for MASH patients)
- For plasma spectroscopy: Cirrhosis
- Anamnesis of alcohol abuse (based on GGT, carbohydrate-deficient transferrin, urinary ethyl-glucuronide, and patient's history)
Who the study is looking for
- Presence of liver steatosis (detected either by hepatic ultrasonography/CAP/histologically) or MASH/simple steatosis confirmed by liver biopsy
- Absence of secondary causes of fat accumulation in the liver and other liver disease: ruled out other etiologies of liver disease, such as viral hepatitis, drug-induced liver disease, autoimmune liver disease, biliary tract disease, and hereditary metabolic diseases
- Absence of liver disease
- For breath analysis: absence of liver steatosis (normal liver ultrasound image and CAP less than 248 dB/m)
- For plasma spectroscopy and bile acid analysis: Body Mass Index ≤ 25 and waist-hip ratio ≤ 0.95 plus normal liver ultrasound
- Absence of diabetes mellitus and metabolic syndrome
- Normal liver function tests, lipid spectrum, fasting glycemia
- Alcohol intake less than 20 g/ day (women) or 30 g/ day (men)
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regional Hospital Liberec Coordinator of this site? Confirm its status | Liberec | Czechia | Unknown status |
| General University Hospital in Prague Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.