The objective of this clinical trial, a pilot study, is to assess the impact of nicotinamide (NAM) on individuals with hepatic fibrosis.
The main question it aims to answer is:
\- To determine if the treatment with NAM is able to arrest, or even reduce, the hepatic fibrosis.
In addition, we also want to study the effect of NAM on:
* General parameters (weight, HOMA-IR, etc). * Adiposity distribution (liver and body). * Systemic inflammation. * Thermogenic capacity of adipose tissue. * Microbiota composition.
Researchers will compare NAM to a placebo, to see if NAM can arrest or revert hepatic fibrosis and its associated effects.
Participants will take either NAM or placebo. The dosage will be 1.2g/m2 NAM per day, for one year.
Patients aged between 18 and 85 years.
Diagnosis of non-alcoholic fatty liver disease (NAFLD) by their referring physicians (NAFLD defined as the presence of hepatic steatosis and in the absence of significant alcohol consumption, having excluded other liver diseases).
BMI between 27-40 kg/m2.
Fibroscan® value greater than 9.2 kPa, obtained within the last 6 months prior to the start of the study.
Patients with any medical condition or illness that, in the opinion of the investigator, could interfere with the study results and/or affect the patients' ability to participate or complete the study.
History of clinically significant heart disease (ejection fraction <40% [normal range 50-70%], heart failure defined as New York Heart Association [NYHA] Class > 2; clinically significant congenital or acquired valvular disease; symptomatic coronary artery disease such as myocardial infarction or angina, history of unstable arrhythmias, history of atrial fibrillation).
Decreased renal function (estimated glomerular filtration rate <45 mL/min/1.73 m2, calculated using the CKD-EPI formula) at screening.
Alcohol consumption exceeding 30 g/day in men or 20 g/day in women.
Parallel
Nicotinamide
DrugAdministration of NAM on a variable dose depending on the participant's body weight. Administration is done orally, daily.
Placebo
DrugAdministration of placebo on a variable dose depending on the participant's body weight. Administration is done orally, daily.
Effect of nicotinamide on hepatic fibrosis
Measurement of hepatic fibrosis by Fibroscan, to asses the arrest or improvement of fibrosis (lower value than basal Fibroscan result)
Effect of nicotinamide on body fat and hepatic fat distribution
Analysis of body and hepatic fat by magnetic ressonance and observe visual differences between the basal and final images
Effect of nicotinamide on the general health state (weight)
Analysis of body weight (grams) and waist circumference (cm), a reduction in both would point to a better general status and a weight loss
Effect of nicotinamide on the general health state (strenght)
Evaluation of the grip strength as a measure of muscle strength
Effect of nicotinamide on the Insulin resistance
Calcutaltion of the HOMA-IR (homeostatic model assessment - Insulin Resistance) index, a reduction of the HOMA-IR index shows a reduction of insulin resistance and an improved glucose metabolism
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Germans Trias i Pujol Hospital
Collaborator
