The Effect of Coenzyme Q10 on Endothelial, Vascular and Myocardial Function

Attikon University Hospital

Status and phase: Enrolling; Phase 2

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Drug: Q10

Study type: Interventional

Funder types: Other

Identifiers

NCT05941910

Q10nafldtrial

Details and patient eligibility

About

Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD

Full description

Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD. In this trial patients with NAFLD will receive 240mg Q10 or placebo. At baseline and at 6 months, will be measured: a) Perfused boundary region (PBR) of the sublingual vessels using the SideviewDarkfieldimaging technique (Microscan, Glycocheck), b) pulse wave velocity (PWV-Complior, ALAM), c) flow-mediated dilation (FMD) of the brachial artery, d) left ventricular (LV) global longitudinal strain (GLS), and e) controlled attenuation parameter (CAP)for the quantification of liver steatosis by liver elastography (Fibroscan, Echosens).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NAFLD AND one of below :

  1. dyslipidemia, as it is defined in the metabolic syndrome
  2. increased waist circumference as defined in the metabolic syndrome
  3. Arterial hypertension,
  4. overweight, (BMI>25)
  5. polycystic ovary syndrome,

Exclusion criteria

• Chronic Kidney Disease
• Heart Failure
• Liver failure
• Pregnancy/ Breast feeding
• Active malignancy (receiving Chemotherapy/immunotherapy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Q10

Active Comparator group

Treatment:

Drug: Q10

Placebo

Placebo Comparator group

Treatment:

Drug: Q10