Metabolic-associated Fatty Liver Disease (MAFLD)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
An observational study of Metabolic-associated Fatty Liver Disease (MAFLD), run by Kazakh Association of Internal Medicine Specialists at 7 sites in Kazakhstan.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic-associated Fatty Liver Disease (MAFLD)
- How many people
- 264 participants
- Where
- 7 sitesKazakhstan
- Study dates
- 8 Feb 2023to 8 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Kazakhstan7 sites, 7 recruiting
- Recruiting
LLP "InkarMed"
Aktobe
Erkin Sartaev, +7707-886-48-86
Dariga Kushimova
- Recruiting
hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
Almaty
Gulshahira Kambarova, +7(727)233-39-61, gkkp5@inbox.ru
Aliya Balabek
- Recruiting
Medical Center "iClinic"
Astana
Alia Rustemova, +7(7172)955-955, hr.iclinic2018@gmail.ru
Venera Rakhmetova
- Recruiting
State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
Esik, Almaty Region
+7(7277)57-32-02, enbekshikaz_crb@mail.ru
Tamilya Rashidova
- Recruiting
Non-profit joint-stock company "Semey Medical University"
Semey
Altai Dyusupov, +7(7222)52-22-51, smu@nao-mus.kz
Aizhan Shakhanova
- Recruiting
Medical center "Gatromed"
Shymkent
Lyazzat Syzdykova, +7701-092-3353, gastromed-2019@mail.ru
Guldana Mutalieva
- 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
Eldos Sultanov, 8(7252)53-63-86, gkkp_okb@mail.ru
Tatyana Kasymova
About this study
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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 12 months since enrollment
Frequency of registration of adverse and serious unexpected adverse events associated with the use of COC and BDD
Measured: up to 12 months since enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start8 Feb 2023
- Primary completion8 Feb 2025 (estimated)
- Study completion8 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic-associated Fatty Liver Disease (MAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakh Association of Internal Medicine Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078722
- Sponsor's protocol ID
- KAIMS-01
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06078722
- Acronym / sponsor ID
- KAIMS-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Kazakh Association of Internal Medicine SpecialistsUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 8 Feb 2025 (estimated)
- Study completion
- 8 Feb 2025 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
Related trials for Metabolic-associated Fatty Liver Disease (MAFLD)
Active, not recruitingObservational study
Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Hyperuricemia and MAFLD
Not yet recruitingObservational study
Liver Stiffness Changes by iLivTouch to Predict Liver-Related Events in MAFLD
MAFLD
Not yet recruitingPhase 4
Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance
MAFLD in Prediabetes and Diabetes
RecruitingPhase 3
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingObservational study
Cardiovascular Risk in T2DM With MAFLD: A Cohort Study
Type 2 Diabetes (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic-associated Fatty Liver Disease (MAFLD), run by Kazakh Association of Internal Medicine Specialists at 7 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aigul Dzhumabaeva (+77015122326, almusa010@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.