Clinical trial of the efficacy and safety of nicotinamide in patients with diabetes mellitus type 2 and liver fibrosis
- Conditions
- Hepatic fibrosisMedDRA version: 20.0Level: PTClassification code: 10019668Term: Hepatic fibrosis Class: 100000004871Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Patients aged between 18 and 85 years., Diagnosis of NASH by their referring physicians (NASH defined as presence of hepatic steatosis and in the absence of significant alcohol consumption and having excluded other liver diseases)., BMI between 30-40 kg/m2., Type 2 DM diagnosed by their referring physicians., Fibroscan® value higher than 9.2kPa., ELF test > 7.7
Patients with any medical condition or disease that, in the opinion of the investigator, could interfere with the results of the study and/or affect the patients' ability to participate in 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 pectoris, 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 greater than 30 g/day in men or 20 g/day in women., Patients with significant alteration of liver function in the screening workup 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 hepatocarcinoma. Patients with liver cirrhosis (Fibroscan® > 18, compatible biopsy or who have suffered decompensation of cirrhosis). Patients diagnosed with human immunodeficiency virus (HIV). Patients with hypersensitivity or history of severe allergy to NAM or excipients used in the preparation of the capsules (NAM and placebo). 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 under 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 patients with no fixed abode. Principal investigator criteria in the case of indications of low adherence to the trial or follow-up visits. People with a life expectancy of less than 12 months. Patients participating in another interventional clinical trial, excluding observational/natural history studies, at baseline or in the last 30 days before the start of the study. Prior use of vitamin B3 (NAM), abstinence must be at least 3 months prior to screening., Pregnant women as determined by a positive hCG test (serum or urine) at screening or prior to dosing. Participants of childbearing age should use adequate contraception. Nursing women., Patients undergoing treatment/supplementation with vitamin E. 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 evolution of liver disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method