Status:
RECRUITING
Effect of CoQ10 on the Outcome of MAFLD Patients
Lead Sponsor:
Ain Shams University
Conditions:
Fatty Liver
NAFLD
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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: ...
Detailed Description
The liver disease with the most continuously rising prevalence rates is metabolic-dysfunction associated fatty liver disease (MAFLD), making us arrive at a conclusion that it might be the liver diseas...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05984745
Start Date
October 31 2023
End Date
December 1 2025
Last Update
March 26 2025
Active Locations (1)
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1
National Hepatology and tropical medicine research institute
Cairo, Egypt