A Study on the Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes Combined With Metabolic-associated Fatty Liver Disease and Its Molecular Mechanisms
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters. The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years;
- •BMI≥25 kg/m²;
- •Diagnosed as type 2 diabetes mellitus patients according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)";
- •HbA1c≤8.5%;
- •Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs;
- •Willing to participate in this study, and after full informed consent, agrees to strictly follow the treatment plan and promises to attend follow-up visits on time, and signs the informed consent form.
排除标准
- •BMI < 25 kg/m²;
- •Age < 18 years, or > 75 years;
- •History of type 1 diabetes, acute pancreatitis, or diabetes secondary to pancreatectomy;
- •History of bariatric surgery or planned bariatric surgery, or currently attempting weight loss within the past 3 months, or use of weight-loss medications within the past 3 months;
- •Use of GLP-1 receptor agonists, sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, or other related drugs within the past 3 months;
- •Pregnant or breastfeeding women, or those planning to conceive during the study period;
- •Patients with severe diseases of important organ systems, such as severe cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, renal insufficiency, hematologic diseases, neurological diseases, or malignancies;
- •Personal or family history of medullary thyroid carcinoma;
- •Patients with severe mental disorders or communication barriers that prevent accurate understanding of the study content and compliance with the trial procedures.
研究组 & 干预措施
semaglutide group
The semaglutide group received weekly subcutaneous semaglutide (0.25 mg for weeks 1-2, 0.5 mg for weeks 3-4, and 1.0 mg for weeks 5-12).
干预措施: semaglutide (Drug)
caloric restriction group
The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females).
干预措施: caloric restriction (Behavioral)
结局指标
主要结局
HbA1c
时间窗: From enrollment to the end of treatment at 12 weeks
glycated hemoglobin
FPG
时间窗: From enrollment to the end of treatment at 12 weeks
fasting plasma glucose
2hPG
时间窗: From enrollment to the end of treatment at 12 weeks
2-hour postprandial glucose
次要结局
- HOMA-IR(From enrollment to the end of treatment at 12 weeks)
- TC(From enrollment to the end of treatment at 12 weeks)
- TG(From enrollment to the end of treatment at 12 weeks)
- LDL-C(From enrollment to the end of treatment at 12 weeks)
- HDL-C(From enrollment to the end of treatment at 12 weeks)