Effect of CoQ10 on the Outcome of MAFLD Patients
Recruiting · NCT05984745 · Interventional (participants receive a specific treatment) · Lead sponsor: Ain Shams University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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):
- Waist circumference (WC) ≥ 102/88 cm for men and women respectively.
- HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy.
- Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy.
- Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy.
- 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)
Where it is running
1 location listed.
- National Hepatology and tropical medicine research institute - Cairo, Egypt