An interventional study of SGLT2 inhibitor and GLP-1 RA in Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) and Type 2 Diabetes Mellitus (T2DM), sponsored by Moscow Regional Research and Clinical Institute (MONIKI). Completed at 1 site in Russia. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Moscow Regional Research and Clinical Institute (MONIKI) · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 130 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
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Non-inclusion criteria:
Exclusion Criteria:
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 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
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.
Drug: GLP-1 RA
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.
Drug: SGLT2 inhibitor · Drug: GLP-1 RA
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 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.
Change in serum HMW-adiponectin levels
Time frame: Baseline and 6 months
Change in liver steatosis (CAP)
Time frame: Baseline, 6 months
Plan to share: No
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Moscow Regional Research and Clinical Institute (MONIKI)