Clinical trial NCT06078722: 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
Official title: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic-associated Fatty Liver Disease (MAFLD)
Lead sponsor: Kazakh Association of Internal Medicine Specialists
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons aged ≥18 to 75 years inclusive with a diagnosis of metabolic-associated fatty liver disease who are undergoing outpatient monitoring at the place of residence.

Brief summary: 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)


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: at 12 months
Secondary outcomes:
measure: Normalization of ALT levels during pathogenetic therapy for MAFLD at 6 months among study participants taking and not taking COC and BDD
timeFrame: at 6 months
measure: Fibrosis level during pathogenetic therapy for MAFLD at 6 and 12 months among study participants taking and not taking COC and BDD
timeFrame: at 6 and 12 months
measure: Steatosis level during pathogenetic therapy for MAFLD at 6 and 12 months among study participants taking and not taking COC and BDD
timeFrame: at 6 and 12 months
measure: Assessment of adherence to COC and BDD therapy against the background of pathogenetic therapy for MAFLD in a cohort taking COC and BDD
timeFrame: up to 12 months since enrollment
measure: 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
timeFrame: up to 12 months since enrollment
measure: 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
timeFrame: up to 12 months since enrollment
measure: 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
timeFrame: up to 12 months since enrollment
measure: Dynamics of carbohydrate metabolism parameters against the background of pathogenetic therapy for MAFLD among study participants taking and not taking COC and BDD
timeFrame: up to 12 months since enrollment
measure: Dynamics of lipid metabolism parameters against the background of pathogenetic therapy for MAFLD among study participants taking and not taking COC and BDD
timeFrame: up to 12 months since enrollment
measure: Frequency of registration of adverse and serious unexpected adverse events associated with the use of COC and BDD
timeFrame: up to 12 months since enrollment
Other outcomes:
Locations:
city: Esik
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
state: Almaty Region
city: Aktobe
country: Kazakhstan
facility: LLP "InkarMed"
city: Almaty
country: Kazakhstan
facility: hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
city: Astana
country: Kazakhstan
facility: Medical Center "iClinic"
city: Semey
country: Kazakhstan
facility: Non-profit joint-stock company "Semey Medical University"
city: Shymkent
country: Kazakhstan
facility: Medical center "Gatromed"
city: Turkestan
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region
Study officials:
References: