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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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