The Effect of Coenzyme Q10 on Endothelial, Vascular and Myocardial Function
The Effect of 6-month Treatment With Coenzyme Q10 on Endothelial, Vascular and Myocardial Function in Patients With Non-alcoholic Fatty Liver Disease
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 12, 2023
July 1, 2023
5 months
June 26, 2023
July 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Q10
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- Chronic Kidney Disease
- Heart Failure
- Liver failure
- Pregnancy/ Breast feeding
- Active malignancy (receiving Chemotherapy/immunotherapy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Attikon Hospitallead
Study Sites (1)
Vaia Lambadiari
Athens, Attica, 12462, Greece
Related Publications (1)
Vrentzos E, Ikonomidis I, Pavlidis G, Katogiannis K, Korakas E, Kountouri A, Pliouta L, Michalopoulou E, Pelekanou E, Boumpas D, Lambadiari V. Six-month supplementation with high dose coenzyme Q10 improves liver steatosis, endothelial, vascular and myocardial function in patients with metabolic-dysfunction associated steatotic liver disease: a randomized double-blind, placebo-controlled trial. Cardiovasc Diabetol. 2024 Jul 10;23(1):245. doi: 10.1186/s12933-024-02326-8.
PMID: 38987784DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine-Endocrinology
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 12, 2023
Study Start
April 1, 2023
Primary Completion
August 14, 2023
Study Completion
December 31, 2023
Last Updated
July 12, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share