Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
Recruiting · NCT06843148 · Interventional (participants receive a specific treatment) · Lead sponsor: Université de Sherbrooke
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis. MASLD results from fat being disproportionately deposited in the liver. The goal of this mechanistic study is to investigate metabolic response in patients aged 20 to 80 years with non-alcoholic fatty liver disease, after niacin (vitamin B3) treatment. The main questions it aims to answer are: * Does Niacin lower the fat deposition in the liver? * Does Niacin raise White Adipose Tissue storage of dietary fatty acids? Researchers will compare Niacin to a placebo (a look-alike substance that contains no drug) to compare the metabolic response. Duration of study per participant: Up to 28 weeks
Who can take part
Inclusion criteria
- aged 20 to 80 years;
- diagnosed with MASLD, defined as the presence of liver steatosis + abdominal obesity (as defined by the International Diabetes Federation country/ethnic group-specific criteria;
Exclusion criteria
- \) Presence of advanced fibrosis using any of the following criteria 1.1 (i.e., ≥ F3 based on liver stiffness \> 10kPa) using vibration-controlled transient elastography (FibroScan), 1.2 (Index for Liver Fibrosis \> 2.67) using Fibrosis-4 (FIB-4) which is a calculated score based on age and a combination of lab tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and platelet count), 1.3 serum ALT \> 3 times the normal upper limit, 1.4 or signs of portal hypertension. 2) Other hepatic disease. 4) Overt cardiovascular or renal disease, cancer (other than non-melanoma skin cancer), or other uncontrolled medical conditions.
- \) Any contraindication to MRI. 6) Previous intolerance or allergy to nicotinic acid. 7) Having participated to a research study with exposure to radiation in the last two years before the start of the study.
- \) Being allergic to eggs 9) Smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day.
- \) Women who are pregnant or breastfeeding.
Where it is running
1 location listed.
- Centre de recherche du CHUS - Sherbrooke, Quebec, Canada