Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)NCT07539584
Adiponectin in Patients With Metabolic Disorders
A study testing SGLT2 inhibitor and GLP-1 RA in people with Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) and Type 2 Diabetes Mellitus (T2DM), run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
Background. Metabolic dysfunction-associated fatty liver disease (MAFLD/MASLD) is highly prevalent in patients with type 2 diabetes mellitus (T2DM) and is associated with insulin resistance. Adiponectin, particularly its high-molecular-weight (HMW) form, is a promising biomarker of metabolic status. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- SGLT2 inhibitor and GLP-1 RA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2022to 8 Apr 2024
- Phase
- Interventional
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of the patient to participate in the study
- Glycated hemoglobin level exceeding the target by no more than 1%.
- Age 40 to 65 years inclusive
- Verified diagnosis of MAFLD, according to the criteria of EASL 2020,
- Confirmed diagnosis of type 2 diabetes mellitus
- Body mass index (BMI) 25-39.9 kg/m2
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- Refusal to take any dietary supplements
- Non-inclusion criteria:
- Chronic alcohol abuse (alcoholic fatty liver disease)
- Insulin-dependent diabetes
- Use of hepatoprotective agents
- High risk of atherosclerotic cardiovascular disease (age > 55 years with coronary, carotid, or lower extremity artery stenosis, or left ventricular hypertrophy)
- Chronic kidney disease
- Chronic heart failure
Who cannot join
- Patient withdrawal of consent
- Pregnancy (if applicable)
- Decompensation of diabetes during therapy
- Development of adverse events associated with therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adiponectin and Its Role in the Treatment of Patients With Metabolic Disorders
Background. Metabolic dysfunction-associated fatty liver disease (MAFLD/MASLD) is highly prevalent in patients with type 2 diabetes mellitus (T2DM) and is associated with insulin resistance. Adiponectin, particularly its high-molecular-weight (HMW) form, is a promising biomarker of metabolic status. However, its role in predicting response to antidiabetic therapy remains unclear.
Objective. To evaluate the association between circulating HMW-adiponectin levels and the clinical course of MAFLD in patients with T2DM receiving different treatment regimens: glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors), and their combination.
Read more
Study Design. Open-label randomized controlled trial.
Population. Adults aged 40-65 years with confirmed T2DM and MAFLD, body mass index 25-39.9 kg/m², with glycated hemoglobin exceeding the target by no more than 1%.
Interventions. Patients were randomized into three intervention groups (n=30 each): SGLT2 inhibitor monotherapy, GLP-1 RA monotherapy, or combination therapy. A control group (n=40) received no drug therapy for MAFLD.
Outcome Measures. Primary outcome: change in serum HMW-adiponectin levels from baseline to 6 months. Secondary outcome: change in liver steatosis measured by Controlled Attenuation Parameter (CAP).
Timeframe. Follow-up duration: 6 months.
Conclusion. This study will determine whether baseline HMW-adiponectin levels predict the reduction in liver steatosis in response to SGLT2 inhibitors, GLP-1 RAs, or their combination in patients with T2DM and MAFLD/MASLD.
- Conditions
- Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Type 2 Diabetes Mellitus (T2DM)
- Being tested
- SGLT2 inhibitor, GLP-1 RA
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
SGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors) are antidiabetic drugs that lower blood glucose by promoting glucosuria, leading to caloric loss and weight reduction. In this study, patients received standard clinical doses (e.g., dapagliflozin 5-10 mg once daily or empagliflozin 10-25 mg once daily) for 6 months.
GLP-1 RADrug
GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists) are antidiabetic drugs that enhance glucose-dependent insulin secretion, suppress glucagon release, delay gastric emptying, and reduce appetite. In this study, patients received standard clinical doses (e.g., liraglutide 1.2-1.8 mg once daily or semaglutide 0.5-1.0 mg once weekly) for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control group received no drug therapy for metabolic dysfunction-associated fatty liver disease (MAFLD). They continued their standard antidiabetic therapy as prescribed by their treating physician without any additional study interventions. All participants in the control group met the same inclusion/exclusion criteria as the intervention groups. |
| SGLT2 inhibitor | Experimental | SGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors) are antidiabetic drugs that lower blood glucose by promoting glucosuria, leading to caloric loss and weight reduction. In this study, patients received standard clinical doses (e.g., dapagliflozin 5-10 mg once daily or empagliflozin 10-25 mg once daily) for 6 months. Receives: Drug: SGLT2 inhibitor |
| GLP-1 RA | Experimental | GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists) are antidiabetic drugs that enhance glucose-dependent insulin secretion, suppress glucagon release, delay gastric emptying, and reduce appetite. In this study, patients received standard clinical doses (e.g., liraglutide 1.2-1.8 mg once daily or semaglutide 0.5-1.0 mg once weekly) for 6 months. Receives: Drug: GLP-1 RA |
| SGLT2 inhibitor + GLP-1 RA | Experimental | Participants received combination therapy with an SGLT2 inhibitor and a GLP-1 receptor agonist for 6 months. The specific drugs, doses, and regimens followed standard clinical practice as per the study protocol. Receives: Drug: SGLT2 inhibitor; Drug: GLP-1 RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum HMW-adiponectin levels
Measured: Baseline and 6 months
Secondary outcomes (1)
Change in liver steatosis (CAP)
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Mar 2022
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Collaborators
- Botkin Hospital, Sechenov University
- Responsible party
- Principal investigator, Alexey Zulkarnaev, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539584
- Sponsor's protocol ID
- Adipo_0222
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiponectin and Its Role in the Treatment of Patients With Metabolic Disorders
- ClinicalTrials.gov ID
- NCT07539584
- Acronym / sponsor ID
- Adipo_0222
- Conditions
- Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Type 2 Diabetes Mellitus (T2DM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Collaborators
- Botkin Hospital, Sechenov University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 20 Apr 2026 (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.
Background. Metabolic dysfunction-associated fatty liver disease (MAFLD/MASLD) is highly prevalent in patients with type 2 diabetes mellitus (T2DM) and is associated with insulin resistance. Adiponectin, particularly its high-molecular-weight (HMW) form, is a promising biomarker of metabolic status. However, its role in predicting response to antidiabetic therapy remains unclear.
Objective. To evaluate the association between circulating HMW-adiponectin levels and the clinical course of MAFLD in patients with T2DM receiving different treatment regimens: glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors), and their combination.
Study Design. Open-label randomized controlled trial.
Population. Adults aged 40-65 years with confirmed T2DM and MAFLD, body mass index 25-39.9 kg/m², with glycated hemoglobin exceeding the target by no more than 1%.
Interventions. Patients were randomized into three intervention groups (n=30 each): SGLT2 inhibitor monotherapy, GLP-1 RA monotherapy, or combination therapy. A control group (n=40) received no drug therapy for MAFLD.
Outcome Measures. Primary outcome: change in serum HMW-adiponectin levels from baseline to 6 months. Secondary outcome: change in liver steatosis measured by Controlled Attenuation Parameter (CAP).
Timeframe. Follow-up duration: 6 months.
Conclusion. This study will determine whether baseline HMW-adiponectin levels predict the reduction in liver steatosis in response to SGLT2 inhibitors, GLP-1 RAs, or their combination in patients with T2DM and MAFLD/MASLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group received no drug therapy for metabolic dysfunction-associated fatty liver disease (MAFLD). They continued their standard antidiabetic therapy as prescribed by their treating physician without any additional study interventions. All participants in the control group met the same inclusion/exclusion criteria as the intervention groups. |
| SGLT2 inhibitor | Experimental | Drug: SGLT2 inhibitorSGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors) are antidiabetic drugs that lower blood glucose by promoting glucosuria, leading to caloric loss and weight reduction. In this study, patients received standard clinical doses (e.g., dapagliflozin 5-10 mg once daily or empagliflozin 10-25 mg once daily) for 6 months. |
| GLP-1 RA | Experimental | Drug: GLP-1 RAGLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists) are antidiabetic drugs that enhance glucose-dependent insulin secretion, suppress glucagon release, delay gastric emptying, and reduce appetite. In this study, patients received standard clinical doses (e.g., liraglutide 1.2-1.8 mg once daily or semaglutide 0.5-1.0 mg once weekly) for 6 months. |
| SGLT2 inhibitor + GLP-1 RA | Experimental | Drug: SGLT2 inhibitor, Drug: GLP-1 RAParticipants received combination therapy with an SGLT2 inhibitor and a GLP-1 receptor agonist for 6 months. The specific drugs, doses, and regimens followed standard clinical practice as per the study protocol. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent of the patient to participate in the study
- Glycated hemoglobin level exceeding the target by no more than 1%.
- Age 40 to 65 years inclusive
- Verified diagnosis of MAFLD, according to the criteria of EASL 2020,
- Confirmed diagnosis of type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- Patient withdrawal of consent
- Pregnancy (if applicable)
- Decompensation of diabetes during therapy
- Development of adverse events associated with therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorSGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors) are antidiabetic drugs that lower blood glucose by promoting glucosuria, leading to caloric loss and weight reduction. In this study, patients received standard clinical doses (e.g., dapagliflozin 5-10 mg once daily or empagliflozin 10-25 mg once daily) for 6 months. | Drug | SGLT2 inhibitor, SGLT2 inhibitor + GLP-1 RA |
| GLP-1 RAGLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists) are antidiabetic drugs that enhance glucose-dependent insulin secretion, suppress glucagon release, delay gastric emptying, and reduce appetite. In this study, patients received standard clinical doses (e.g., liraglutide 1.2-1.8 mg once daily or semaglutide 0.5-1.0 mg once weekly) for 6 months. | Drug | GLP-1 RA, SGLT2 inhibitor + GLP-1 RA |
Primary outcome
Change in serum HMW-adiponectin levels
Time frame: Baseline and 6 months
1 secondary outcome
Change in liver steatosis (CAP)
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGLT2 inhibitor and GLP-1 RA in people with Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) and Type 2 Diabetes Mellitus (T2DM), run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
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 14 inclusion and 4 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: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum HMW-adiponectin levels (time frame: Baseline and 6 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 22 Apr 2026.