Effect of CoQ10 on the Outcome of MAFLD Patients

Launched by AIN SHAMS UNIVERSITY · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called coenzyme Q10 (CoQ10) on patients with a condition called Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). MAFLD is a complex liver problem that often arises from factors like obesity, diet, and genetics. While there is no one-size-fits-all treatment for MAFLD, lifestyle changes such as healthy eating, weight loss, and exercise are very important. Researchers believe that high doses of CoQ10 may help reduce inflammation and improve health markers in patients with this condition, and they want to test this idea.

To participate in this trial, you should be an adult over 18 years old, and you’ll need to meet certain health criteria related to metabolic issues, including having a larger waist size, elevated cholesterol or triglycerides, high blood pressure, or blood sugar levels. Participants will undergo a few tests to confirm their eligibility, and if accepted, they can expect to take CoQ10 and attend follow-ups to monitor their health. It's important to note that some people, such as those with certain liver conditions or those taking specific medications, may not be eligible for this study. If you're interested in learning more or think you might qualify, please reach out for more information.

Gender

ALL

Eligibility criteria

• 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)