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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Q10
Sponsored by
Attikon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Non-alcoholic fatty liver disease, endothelial function, vascular function, myocardial function, coronary flow reserve, endothelial glycocalyx, flow mediated dilation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vaia LambadiariRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Q10

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 26, 2023
Last Updated
July 4, 2023
Sponsor
Attikon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05941910
Brief Title
The Effect of Coenzyme Q10 on Endothelial, Vascular and Myocardial Function
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
August 14, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Non-alcoholic fatty liver disease, endothelial function, vascular function, myocardial function, coronary flow reserve, endothelial glycocalyx, flow mediated dilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Q10
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Q10
Intervention Description
240mg of Q10 orally, every day
Primary Outcome Measure Information:
Title
The effect of Q10 on Left Ventricular Myocardial Function
Description
The effect of Q10 on Left Ventricular Global Longitudinal Strain after six month administration of Q10
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vaia Lambadiari, Profesor
Phone
2105831148
Email
vlambad@otenet.gr
Facility Information:
Facility Name
Vaia Lambadiari
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaia Lambadiari, Professor
Phone
2105831148
Email
vlambad@otenet.gr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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