Clinical trial
The Effect of 6-month Treatment With Coenzyme Q10 on Endothelial, Vascular and Myocardial Function in Patients With Non-alcoholic Fatty Liver Disease
Name
Q10nafldtrial
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
Trial arms
Trial start
2023-04-01
Estimated PCD
2023-08-14
Trial end
2023-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Q10
240mg of Q10 orally, every day
Arms:
Placebo, Q10
Size
60
Primary endpoint
The effect of Q10 on Left Ventricular Myocardial Function
Six months
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-07-12
1 organization
1 product
1 indication
Organization
Attikon HospitalProduct
Q10Indication
Nonalcoholic Fatty Liver Disease