Study of the Efficacy and Safety of Nicotinamide in Patients with Diabetes Mellitus Type 2 and Liver Fibrosis (NICOFIB)
Status:
RECRUITING
Trial end date:
2028-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE2
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau