Evaluation of the Effectiveness of the Use of a Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the Pathogenetic Therapy of Metabolic-associated Fatty Liver Disease: a Prospective Cohort Study

Study Overview
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Brief Summary
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The goal of this observational study is to learn the effectiveness and safety of the use of Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the pathogenetic therapy of metabolic-associated fatty liver disease (MAFLD)

Official Title
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Evaluation of the Effectiveness of the Use of a Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the Pathogenetic Therapy of Metabolic-associated Fatty Liver Disease: a Prospective Cohort Study

Conditions
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Metabolic-associated Fatty Liver Disease (MAFLD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes aged 18 to 75 years, who are citizens of the Republic of Kazakhstan; Patients with a clinically and laboratory confirmed diagnosis of MAFLD, without severe concomitant diseases; Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others); Patients who have at least a 7-day gap between the end of other adjuvant therapy and the start of COC and BDD; Patients who voluntarily signed the informed consent form. Exclusion Criteria: Patients who abuse alcohol according to the AUDIT-c questionnaire; Patients taking COC for more than 4 weeks before signing the informed consent; Patients with contraindications to COC; Patients diagnosed with diabetes mellitus; Pregnancy and lactation; Simultaneous use of levodopa, altretamine, cisplatin, statins; Patients with coinfection with HIV, HBV, HCV; Decompensated liver cirrhosis CPT≥7 points; GFR ≤ 15 ml/min/1.73 m2; Drug-induced liver damage; Taking narcotic and psychotropic drugs; Malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than >5 times; patients with pronounced biochemical activity (ALT, AST more than 10 ULN) and total bilirubin more than 2 ULN; Participation in an interventional clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Cohort<br>Patients taking Carnitine-Orotate Complex and BDD regardless of study participation. The duration of observation for taking COCs and BDD is 6 months, and the duration of follow-up is 6 months. | |
| Control cohort<br>Patients who do not take Carnitine-Orotate Complex and BDD, regardless of study participation. Duration of patient observation - 12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of ALT levels during pathogenetic therapy for MAFLD at 12 months among study participants taking and not taking carnitine-orotate complex(COC) and biphenyl dimethyl dicarboxylate(BDD) |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of ALT levels during pathogenetic therapy for MAFLD at 6 months among study participants taking and not taking COC and BDD |  | at 6 months | 
| Fibrosis level during pathogenetic therapy for MAFLD at 6 and 12 months among study participants taking and not taking COC and BDD |  | at 6 and 12 months | 
| Steatosis level during pathogenetic therapy for MAFLD at 6 and 12 months among study participants taking and not taking COC and BDD |  | at 6 and 12 months | 
| Assessment of adherence to COC and BDD therapy against the background of pathogenetic therapy for MAFLD in a cohort taking COC and BDD |  | up to 12 months since enrollment | 
| Assessment of the impact of COC and BDD against the background of pathogenetic therapy for MAFLD on the quality of life of study participants taking and not taking COC and BDD |  | up to 12 months since enrollment | 
| Absolute and relative risks calculation of cardiovascular diseases developing when taking COC and BDD against the background of pathogenetic therapy for MAFLD, as well as comparison among study participants taking and not taking COC and BDD |  | up to 12 months since enrollment | 
| Absolute and relative risks calculation of type 2 diabetes mellitus developing when taking COC and BDD against the background of pathogenetic therapy for MAFLD, as well as comparison among study participants taking and not taking COC and BDD |  | up to 12 months since enrollment | 
| Dynamics of carbohydrate metabolism parameters against the background of pathogenetic therapy for MAFLD among study participants taking and not taking COC and BDD |  | up to 12 months since enrollment | 
| Dynamics of lipid metabolism parameters against the background of pathogenetic therapy for MAFLD among study participants taking and not taking COC and BDD |  | up to 12 months since enrollment | 
| Frequency of registration of adverse and serious unexpected adverse events associated with the use of COC and BDD |  | up to 12 months since enrollment |