Effect of CoQ10 on the Outcome of MAFLD Patients
NCT05984745
Summary
So far there has been no universal treatment for MAFLD since it has a complex etiology that involves ethnic, genetic, metabolic and environmental factors. However, therapeutic life changes including: diet, weight loss, and physical activity remain the cornerstone of treatment and is recommended by both American and European associations. Inflammatory biomarkers, such as tumor necrosis factor-alpha, and adipokines play key roles in the pathogenesis of MAFLD, hence, the anti-inflammatory and antioxidant effects of coenzyme Q10 especially at high doses that have not been tested are hypothesized to have a beneficial role in improving the systemic inflammation and biochemical variables. This study is conducted to test this hypothesis
Eligibility
Inclusion Criteria: All study subjects and prior to consenting to the ICF, laboratory and imaging work-up will be evaluated for the presence of three out of five criteria for metabolic dysregulation in the context of metabolic -dysfunction associated fatty liver disease (MAFLD): 1. Waist circumference (WC) ≥ 102/88 cm for men and women respectively. 2. HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy. 3. Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy. 4. Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy. 5. Fasting blood glucose ≥ 100 mg/dl or on specific anti hyperglycemic therapy * Patients who agree to sign an informed consent * Adult patients \>18 years old. * Males and females * Willing to comply with procedures and follow up * Elevated serum transaminases (1-4 times the ULN) * Imaging evidence of fatty liver: pelviabdominal ultrasound and Fibro- CAP study Exclusion Criteria: * Pregnancy or lactating * Physical or mental abnormalities * HCV infection * HBV infection * Anaemia * Thrombocytopenia * Haematological malignancies * Ongoing alcoholism (Male: \>30g/day, Female: \>20g/day) * Patients with renal failure * Autoimmune hepatitis * Celiac disease * Wilson's disease * Hemochromatosis * Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants, All anti-oxidative stress agents, Cos, IUD * Chronic use of systematically immunosuppressive agent or drugs that can affect liver profile. * Hypo/Hyper-thyroidism * Bypass surgeries * TPN (Total Parenteral Nutrition)
Conditions3
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NCT05984745