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

NCT06078722 | Unknown

• 1 other identifier: KAIMS-01
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 7

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)

Conditions

Metabolic-associated Fatty Liver Disease (MAFLD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kazakh Association of Internal Medicine Specialists: lead

Study Sites (7)

State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"

Esik, Almaty Region, Kazakhstan

RECRUITING

LLP "InkarMed"

Aktobe, Kazakhstan

RECRUITING

hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"

Almaty, Kazakhstan

RECRUITING

Medical Center "iClinic"

Astana, Kazakhstan

RECRUITING

Non-profit joint-stock company "Semey Medical University"

Semey, Kazakhstan

RECRUITING

Medical center "Gatromed"

Shymkent, Kazakhstan

RECRUITING

State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region

Turkestan, Kazakhstan

RECRUITING

Central Study Contacts

Aigul Dzhumabaeva

CONTACT

+77015122326; almusa010@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 12, 2023
• Study Start: February 8, 2023
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: October 12, 2023

Record last verified: 2023-09

Locations

KA (7)