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

• Sponsor: Attikon Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05941910
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 6.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Drug: Q10	Phase 2

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Aug 14, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Q10	Drug: Q10; 240mg of Q10 orally, every day
Placebo Comparator: Placebo	Drug: Q10; 240mg of Q10 orally, every day

Outcome Measures

Primary Outcome Measures

1. The effect of Q10 on Left Ventricular Myocardial Function [Six months]

   The effect of Q10 on Left Ventricular Global Longitudinal Strain after six month administration of Q10

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vaia Lambadiari	Athens	Attiki	Greece	12462

Sponsors and Collaborators

• Attikon Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VAIA LAMBADIARI, Professor of Internal Medicine-Endocrinology, Attikon Hospital
• ClinicalTrials.gov Identifier: NCT05941910
• Other Study ID Numbers: Q10nafldtrial
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by VAIA LAMBADIARI, Professor of Internal Medicine-Endocrinology, Attikon Hospital: Non-alcoholic fatty liver disease; endothelial function; vascular function; myocardial function; coronary flow reserve; endothelial glycocalyx; flow mediated dilation
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jul 12, 2023