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

Phase 2

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: Q10

• Registration Number: NCT05941910
• Lead Sponsor: Attikon Hospital

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-06-26
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-04
• Last Update Submitted: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Primary Completion: 2023-08-14
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Q10	Q10	-
Placebo	Q10	-

Primary Outcome Measures

Name	Time	Method
The effect of Q10 on Left Ventricular Myocardial Function	Six months	The effect of Q10 on Left Ventricular Global Longitudinal Strain after six month administration of Q10

Trial Locations

Locations (1)

Vaia Lambadiari; 🇬🇷 Athens, Attiki, Greece