Clinical Trial

Adiponectin in Patients With Metabolic Disorders

Completed
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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. 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-13.
Trial Details
NCT Number NCT07539584
Lead Sponsor Moscow Regional Research and Clinical Institute (MONIKI)
Collaborators: Botkin Hospital, Sechenov University
Conditions Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Type 2 Diabetes Mellitus (T2DM)
Enrollment 130 participants
Start Date 2022-03-01
Primary Completion 2024-04-08 (estimated)
Study Completion 2024-04-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-22