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NCT Number: NCT07539584

Adiponectin in Patients With Metabolic Disorders

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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Key information

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus (T2DM)

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moscow Regional Research and Clinical Institute

Moscow, 129110, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in serum HMW-adiponectin levels

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Change in liver steatosis (CAP)

    Time frame: Baseline, 6 months

Sponsors and collaborators

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Other Gov

Collaborators

  • Botkin Hospital
  • Sechenov University

Registry information

Official study title

Adiponectin and Its Role in the Treatment of Patients With Metabolic Disorders

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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