Status
Completed
Phase
Not applicable
Enrollment
130
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
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
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.
Timeline
First posted
Apr 20, 2026
Study start
Mar 1, 2022
Primary completion
Apr 8, 2024
Study completion
Apr 8, 2024
Results posted
Not reported
Registry updated
Apr 22, 2026
Outcomes
Change in serum HMW-adiponectin levels
Time frame · Baseline and 6 months
Change in liver steatosis (CAP)
Time frame · Baseline, 6 months
Eligibility
Inclusion Criteria: * 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 Exclusion Criteria: * Patient withdrawal of consent * Pregnancy (if applicable) * Decompensation of diabetes during therapy * Development of adverse events associated with therapy.
Study locations
Russia. Showing up to 24 locations stored in the fast local snapshot.
Moscow Regional Research and Clinical Institute
Moscow, Russia
Publications
No PMID-linked publications were present in this registry snapshot.
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