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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-12-31

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

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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).

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Q10

Group Type ACTIVE_COMPARATOR

Q10

Intervention Type DRUG

240mg of Q10 orally, every day

Placebo

Group Type PLACEBO_COMPARATOR

Q10

Intervention Type DRUG

240mg of Q10 orally, every day

Interventions

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Q10

240mg of Q10 orally, every day

Intervention Type DRUG

Eligibility Criteria

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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,