NCT07539584Completed
Adiponectin in Patients With Metabolic Disorders
Adiponectin and Its Role in the Treatment of Patients With Metabolic Disorders
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 13 Apr 2026
- Start date
- 1 Mar 2022
- Primary completion date
- 8 Apr 2024
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- NCT number
- NCT07539584
What you commit to
- Study type: Interventional
- Participants enrolled: 130
- From 1 Mar 2022 to the primary completion date, 8 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Development of adverse events associated with therapy.
Other illness
- Decompensation of diabetes during therapy
Other
- Patient withdrawal of consent
- Pregnancy (if applicable)
Who the study is looking for
- 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
- 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
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moscow Regional Research and Clinical Institute Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.