Effect of Coenzyme Q10 on the Outcome of Metabolic Dysfunction-Associated Fatty Liver Disease Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

∙ 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

Locations
Other Locations
Egypt
National Hepatology and tropical medicine research institute
RECRUITING
Cairo
Contact Information
Primary
Mariam Seif
mariam.talaat@pharma.asu.edu.eg
+201112720114
Time Frame
Start Date: 2023-10-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
No_intervention: Control group
Patients will receive the standard conventional care which is mainly therapeutic life changes
Experimental: Test Group
Patients will receive Coenzyme Q10 Forte® (MEPACO Pharmaceutical Company, Cairo, Egypt) capsules in a dose of 100 mg twice per day 1 capsule every 12 hours for twelve weeks, in addition to the standard conventional care.
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov