Evaluating Nicotinamide for Liver Fibrosis in Type 2 Diabetes Patients
Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients With and Liver Fibrosis (NICOFIB)
This study is testing if a supplement called nicotinamide can help people with type 2 diabetes and liver scarring feel better and improve their liver health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06599918 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of nicotinamide (NAM) in patients with type 2 diabetes and hepatic fibrosis. Participants will be randomly assigned to receive either NAM or a placebo for a duration of one year. The study will monitor various health parameters, including weight, inflammation, and liver health, through multiple follow-up visits. The primary goal is to determine if NAM can halt or reduce the progression of liver fibrosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with type 2 diabetes, a BMI between 30-40 kg/m2, and a Fibroscan value greater than 9.2 kPa indicating hepatic fibrosis.
Not a fit: Patients with significant heart disease or other medical conditions that could interfere with the study outcomes may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with liver fibrosis associated with type 2 diabetes.
How similar studies have performed: While there is ongoing research into the effects of nicotinamide, this specific approach targeting liver fibrosis in type 2 diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 27-40 kg/m2. * 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.
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Didac Mauricio, Md PhD
- Email: dmauricio@santpau.cat
- Phone: 003493 556 57 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.