Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Cohort | 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 | Patients who do not take Carnitine-Orotate Complex and BDD, regardless of study participation. Duration of patient observation - 12 months. |
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aigul Dzhumabaeva | Contact | +77015122326 | almusa010@mail.ru |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital" | Recruiting | Esik | Almaty Region | Kazakhstan |
Not provided
Not provided
Not provided
Not provided
| 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 |
| LLP "InkarMed" | Recruiting | Aktobe | Kazakhstan |
|
| hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5" | Recruiting | Almaty | Kazakhstan |
|
| Medical Center "iClinic" | Recruiting | Astana | Kazakhstan |
|
| Non-profit joint-stock company "Semey Medical University" | Recruiting | Semey | Kazakhstan |
|
| Medical center "Gatromed" | Recruiting | Shymkent | Kazakhstan |
|
| State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region | Recruiting | Turkestan | Kazakhstan |
|