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

Kazakh Association of Internal Medicine Specialists

Status: Enrolling

Conditions: Metabolic-associated Fatty Liver Disease (MAFLD)

Study type: Observational

Funder types: Other

Identifiers

NCT06078722

KAIMS-01

Details and patient eligibility

About

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)

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

264 participants in 2 patient groups

Study Cohort

Description:

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

Description:

Patients who do not take Carnitine-Orotate Complex and BDD, regardless of study participation. Duration of patient observation - 12 months.