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

October 3, 2023 updated by: Kazakh Association of Internal Medicine Specialists
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)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kazakhstan
      • Aktobe, Kazakhstan
        • Recruiting
        • LLP "InkarMed"
        • Contact:
          • Erkin Sartaev
          • Phone Number: +7707-886-48-86
        • Sub-Investigator:
          • Dariga Kushimova
      • Almaty, Kazakhstan
        • Recruiting
        • Hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
        • Contact:
          • Gulshahira Kambarova
          • Phone Number: +7(727)233-39-61
          • Email: gkkp5@inbox.ru
        • Sub-Investigator:
          • Aliya Balabek
        • Sub-Investigator:
          • Asya Ergalieva
        • Sub-Investigator:
          • Aizhan Muratbekova
        • Sub-Investigator:
          • Aliya Kaysina
        • Sub-Investigator:
          • Dinara Suleimenova
      • Astana, Kazakhstan
        • Recruiting
        • Medical Center "iClinic"
        • Sub-Investigator:
          • Venera Rakhmetova
        • Contact:
        • Sub-Investigator:
          • Aida Orazbaeva
      • Semey, Kazakhstan
        • Recruiting
        • Non-profit joint-stock company "Semey Medical University"
        • Contact:
        • Sub-Investigator:
          • Aizhan Shakhanova
        • Sub-Investigator:
          • Alida Kaskabaeva
        • Sub-Investigator:
          • Zauresh Zhumadilova
      • Shymkent, Kazakhstan
        • Recruiting
        • Medical center "Gatromed"
        • Contact:
        • Sub-Investigator:
          • Guldana Mutalieva
      • Turkestan, 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
        • Sub-Investigator:
          • Tatyana Kasymova
        • Contact:
    • Almaty Region
      • Esik, Almaty Region, Kazakhstan
        • Recruiting
        • State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
        • Sub-Investigator:
          • Tamilya Rashidova
        • Contact:
        • Sub-Investigator:
          • Guldaria Zaurbaeva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Normalization of ALT levels during pathogenetic therapy for MAFLD at 6 months among study participants taking and not taking COC and BDD
Time Frame: at 6 months
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
Time Frame: at 6 and 12 months
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
Time Frame: at 6 and 12 months
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
Time Frame: up to 12 months since enrollment
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
Time Frame: up to 12 months since enrollment
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
Time Frame: up to 12 months since enrollment
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
Time Frame: up to 12 months since enrollment
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
Time Frame: up to 12 months since enrollment
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
Time Frame: up to 12 months since enrollment
up to 12 months since enrollment
Frequency of registration of adverse and serious unexpected adverse events associated with the use of COC and BDD
Time Frame: up to 12 months since enrollment
up to 12 months since enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kazakh Association of Internal Medicine Specialists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Estimated)

February 8, 2025

Study Completion (Estimated)

February 8, 2025

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAIMS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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