Study of the Efficacy and Safety of Nicotinamide in Patients with Diabetes Mellitus Type 2 and Liver Fibrosis (NICOFIB)

Launched by FUNDACIÓ INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU · Sep 12, 2024

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ClinConnect Summary

The NICOFIB trial is a clinical study looking at the effects of a treatment called nicotinamide (NAM) on patients with Type 2 diabetes and liver fibrosis, which is a condition where the liver becomes damaged and scarred. The main goal is to see if NAM can stop or even reduce this liver damage. Researchers will compare NAM to a placebo (a harmless pill that contains no active medication) over the course of one year to determine its effectiveness. They will also look at how NAM affects weight, body fat distribution, inflammation, and gut bacteria.

To participate in this trial, individuals must be between 18 and 85 years old, have been diagnosed with non-alcoholic fatty liver disease and Type 2 diabetes, and have a certain level of liver stiffness measured by a Fibroscan. Participants will take either NAM or a placebo daily for a year. It's important for potential participants to know that there are specific health conditions that could exclude them from the study, such as significant heart or liver issues, certain infections, or if they are on certain medications. If you're interested in learning more about the study or think you might qualify, please talk to your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 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 30-40 kg/m2.
• • Type 2 diabetes mellitus (T2DM) diagnosed by their referring physicians.
• • Fibroscan® value greater than 9.2 kPa, obtained within the last 6 months prior to the start of the study.
• Exclusion Criteria:
• • 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.
• • Patients with significant impairment of liver function in the selection analysis defined as repeated values of AST, ALT, and bilirubin \> 3 times the upper limit of normal.
• • Positive for hepatitis B surface antigen or hepatitis C antibodies.
• • Patients with hepatocellular carcinoma.
• • Patients with liver cirrhosis (Fibroscan® \> 18, compatible biopsy, or those who have experienced decompensations of cirrhosis).
• • Patients diagnosed with human immunodeficiency virus (HIV).
• • Patients with hypersensitivity or a history of severe allergies to NAM or excipients used in the preparation of capsules (NAM and placebo).
• • Patients with iodinated contrast allergy.
• • History or evidence of an autoimmune disorder considered clinically significant by the investigator or requiring systemic, chronic use of systemic corticosteroids or other immunosuppressants.
• • Patients on treatment with hepatotoxic drugs (amiodarone, immunosuppressants, ART, antituberculosis drugs, corticosteroids, etc.).
• • Patients consuming narcotic and psychotropic substances with hepatotoxic effects.
• • Individuals with incapacitating diseases or cognitive impairment.
• • Institutionalized patients or those without a fixed address.
• • Principal investigator's discretion in case of indications of low adherence to the trial or follow-up visits.
• • Individuals with a life expectancy of less than 12 months.
• • Patients participating in another interventional clinical trial, excluding observational/natural history studies, at the start of the study or within the last 30 days before the start of the study.
• • Previous use of vitamin B3 (NAM), with abstinence required for at least 3 months before screening.
• • Pregnant women as determined by a positive high-sensitivity serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of hCG) within 24 hours prior to screening, dosing, or completion of the study. Women of childbearing potential (WOCBP) will undergo a pregnancy test (serum or urine) 24 hours prior to screening, dosing, or completion of the study. Such participants must use a highly effective contraceptive method, such as combined hormonal contraceptives or intrauterine device (IUD), in accordance with the Clinical Trial Facilitation Group, throughout the entire study.
• • Breastfeeding women.
• • Patients undergoing treatment/supplementation with vitamin E.
• • Patients receiving probiotics.
• • Patients on the waiting list for bariatric surgery in the next 12 months.
• • Patients undergoing treatment with drugs that may have an effect on the progression of liver disease.
• • Drugs for the treatment of T2DM with effects on NAFLD (GLP-1 analogs, thiazolidinediones such as pioglitazone) initiated within 6 months before the study start.
• • Drugs for the treatment of T2DM with effects on intestinal microbiota (metformin, α-GI inhibitors, DPP-4 inhibitors, and SGLT-2 inhibitors) initiated within 6 months before the study start.
• • Patients who do not sign the informed consent.
• • Patients with contraindications to the contrast agent to be used in imaging tests.