Adiponectin in Patients With Metabolic Disorders

NCT07539584 | Completed

• 1 other identifier: Adipo_0222
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD); Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change in serum HMW-adiponectin levels

  Baseline and 6 months

Secondary Outcomes (1)

• Change in liver steatosis (CAP)

  Baseline, 6 months

Study Arms (4)

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.

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.

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.

Drug: SGLT2 inhibitor; Drug: GLP-1 RA

Interventions

SGLT2 inhibitor 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.

SGLT2 inhibitor; SGLT2 inhibitor + GLP-1 RA

GLP-1 RA 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.

GLP-1 RA; SGLT2 inhibitor + GLP-1 RA

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Patient withdrawal of consent
• Pregnancy (if applicable)
• Decompensation of diabetes during therapy
• Development of adverse events associated with therapy.

Sponsors & Collaborators

• Botkin Hospital: collaborator
• Sechenov University: collaborator
• Moscow Regional Research and Clinical Institute (MONIKI): lead

Study Sites (1)

Moscow Regional Research and Clinical Institute

Moscow, 129110, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: March 1, 2022
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)