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NCT05941910 Clinical Trial

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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:
The Effect of 6-month Treatment With Coenzyme Q10 on Endothelial, Vascular and Myocardial Function in Patients With Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05941910
Other study ID # Q10nafldtrial
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 1, 2023
Est. completion date December 31, 2023

Study information
Verified date July 2023
Source Attikon Hospital
Contact Vaia Lambadiari, Profesor
Phone 2105831148
Email vlambad@otenet.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date August 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Q10
240mg of Q10 orally, every day

Locations
Country Name City State
Greece Vaia Lambadiari Athens Attiki

Sponsors (1)
Lead Sponsor Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect of Q10 on Left Ventricular Myocardial Function The effect of Q10 on Left Ventricular Global Longitudinal Strain after six month administration of Q10 Six months
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