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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: Q10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NAFLD AND one of below : dyslipidemia, as it is defined in the metabolic syndrome increased waist circumference as defined in the metabolic syndrome Arterial hypertension, overweight, (BMI>25) polycystic ovary syndrome, Exclusion Criteria: Chronic Kidney Disease Heart Failure Liver failure Pregnancy/ Breast feeding Active malignancy (receiving Chemotherapy/immunotherapy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Q10<br> | Drug: Q10<br>* 240mg of Q10 orally, every day<br>|
| Placebo Comparator: Placebo<br> | Drug: Q10<br>* 240mg of Q10 orally, every day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-alcoholic fatty liver disease, endothelial function, vascular function, myocardial function, coronary flow reserve, endothelial glycocalyx, flow mediated dilation