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Effect of CoQ10 on the Outcome of MAFLD Patients

RECRUITINGPhase 2Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2023-10-31
Est. completion2025-07
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Fatty LiverLiver DiseaseNAFLD

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