*Translating the Adipose Tissue-liver axis in Metabolic dysfunction associated SteatoHepatitis: finding inflammatory therapeutic targets and biomarkers*
- Conditions
- Metabolic Dysfunction associated steatohepatitis (MASH)10019654
- Registration Number
- NL-OMON56912
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 308
subject must be eligible for abdominal surgery (bariatric, gallbladder or
other) and between 18 and 75 years of age. The additional inclusion criterion
for the control group will be BMI<25 and for the overweight/obese patients
BMI>25.
- Evidence of MASLD (based on biopsy or fibroscan measurements) for lean
(BMI<25) control individuals
- Alcohol consumption > 2 per day for women; >3 per day for men
- Drug abuse
- Known viral hepatitis or other infection
- Hepatic cancer
- Elevated CRP levels (>10)
- Diabetes mellitus type 1 or other autoimmune diseases
- Use of anti-inflammatory drugs (specifically corticosteroids)
- For patients without type 2 diabetes: use of anti-diabetes drugs due to their
known effect on inflammation (e.g. metformin, GLP1 mimetics)
- - Pregnancy or breastfeeding
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Immune cell signature in blood, AT and liver<br /><br>- Inflammatory mediators in blood, AT and liver<br /><br>- Liver phenotype: MASLD activity score (histology), composite scores (MASLD<br /><br>fibrosis score, FIB-4) and ALAT/ASAT plasma levels</p><br>
- Secondary Outcome Measures
Name Time Method <p> Potential confounders:<br /><br>- BMI, waist circumference<br /><br>- Metabolic profile: fasting glucose, HbA1c, fasting insulin, HOMA-IR, plasma<br /><br>lipids<br /><br>- Age<br /><br>- Sex<br /><br>- Ethnicity<br /><br>- Alcohol consumption<br /><br>- Smoking<br /><br>- Medication use<br /><br>- Blood pressure</p><br>