Status:
NOT_YET_RECRUITING
Ketogenic Diet in MASLD-related cACLD
Lead Sponsor:
University of Palermo
Conditions:
Steatohepatitis, Nonalcoholic
Steatosis of Liver
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized...
Detailed Description
The rationale of the study stems from evidence that patients with "compensated advanced chronic liver disease" (cACLD) secondary to MASLD have higher risk of liver-related morbidity (liver decompensat...
Eligibility Criteria
Inclusion
- Patients older than 18 years
- Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and/or fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor.
- Informed consent form obtained before any trial-related ac.vity.
Exclusion
- Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA\<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \<1:160), . .
- MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively.
- History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention.
- Recent significant weight loss ( \> 5 % within previous 6 months)
- Presence of large esophageal varices (F2 or F3)
- Decompensated liver cirrhosis and/or presence of hepatocarcinoma and/or portal thrombosis.
- Be pregnant or breasxeeding.
- Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\<30 ml/min).
- Therapy with SGLT-2 inhibitors and/or GLP-1 agonist started within 6 months of screening visit.
- Recent (within 6 months of screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid)
- Any additional condition that might interfere with optimal participation in the study, according to investigators opinion
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06537466
Start Date
November 1 2024
End Date
November 1 2026
Last Update
August 5 2024
Active Locations (1)
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1
Section of Gastroenterology, PROMISE, University of Palermo
Palermo, Italy