Adiponectin and Its Role in the Treatment of Patients With Metabolic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in serum HMW-adiponectin levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient withdrawal of consent
- •Pregnancy (if applicable)
- •Decompensation of diabetes during therapy
- •Development of adverse events associated with therapy.
研究组 & 干预措施
Control
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 + 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.
干预措施: GLP-1 RA (Drug)
SGLT2 inhibitor
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.
干预措施: SGLT2 inhibitor (Drug)
GLP-1 RA
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.
干预措施: GLP-1 RA (Drug)
SGLT2 inhibitor + 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.
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Change in serum HMW-adiponectin levels
时间窗: Baseline and 6 months
次要结局
- Change in liver steatosis (CAP)(Baseline, 6 months)
研究者
Alexey Zulkarnaev
MD, PhD, Professor
Moscow Regional Research and Clinical Institute (MONIKI)