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NCT06843148 | NOT YET RECRUITING | Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Stimulating Fat Tissue Storage with Niacin to Reduce Fat Accumulation in the Liver.
Sponsor:

University of Sherbrooke

Information provided by (Responsible Party):

André Carpentier

Brief Summary:

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 50 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

Condition or disease

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Liver Fibrosis/NASH

Non-Alcoholic Steato-Hepatitis (NASH)

Intervention/treatment

Niacin (250mg)

Placebo Oral Tablet

Phase

NA

Detailed Description:

It will be a randomized crossover study with two 12-week treatment phases (niacin vs. placebo) with a 4-week washout period between the two treatment phases. The two 12-week treatment phases will be performed in random order. The treatment will be administered once daily, at the end of the largest meal. There will be a 3-week dose escalation: from 250mg (the first week) to 750mg from week 3 onward. The outcomes will be assessed at the end of each of these two treatment phases in all participants with metabolic visit A and B (i.e., a total of 4 metabolic visits). Each metabolic visit will last 9 hours: it will be a test meal with perfusion of stable tracers, blood sampling, PET acquisitions using radiopharmaceuticals (18FTHA and 11C-palmitate) and MRI acquisitions. The two visits A and B will be performed without and with acute administration of niacin with the test meal, respectively, to determine acute niacin-induced reduction in hepatic fatty acid flux. The two visits will be performed at four to seven-day interval, in random order during the last week of each of the treatment phase.

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : QUADRUPLE
Primary Purpose : BASIC_SCIENCE
Official Title : Stimulating Adipose Tissue Fatty Acid Disposal with Low-dose, Postprandial, Intermittent Niacin for the Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).
Actual Study Start Date : 2025-04
Estimated Primary Completion Date : 2030-03
Estimated Study Completion Date : 2030-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * aged 50 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;
  • * all women will be post-menopausal.
Exclusion Criteria
  • 1. Presence of advanced fibrosis (i.e., ≥ F3 based on liver stiffness \> 10kPa) using vibration-controlled transient elastography (FibroScan), serum ALT \> 3 times the normal upper limit, or signs of portal hypertension \[106-109\].
  • 2. Other hepatic disease.
  • 3. Previous diagnosis of diabetes.
  • 4. Overt cardiovascular or renal disease, cancer (other than non-melanoma skin cancer), or other uncontrolled medical conditions.
  • 5. 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.
  • 8. Being allergic to eggs
  • 9. Smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day.
Stimulating Fat Tissue Storage with Niacin to Reduce Fat Accumulation in the Liver.

Location Details

NCT06843148

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How to Participate

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Locations

Not yet recruiting

Canada, Quebec

Chus research center

Sherbrooke, Quebec, Canada, J1H 5N4