Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Triglyceride
研究概览
简要总结
The purpose of this study is to analyze the effects of GLP-1RA on blood glucose, body weight, glucose and lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes mellitus.
详细描述
Specific research contents: To study the characteristics of glucose and lipid metabolism and fat distribution in overweight/obesity patients with type 2 diabetes mellitus; liraglutide/ semaglutide/ metformin will be applied to patients for one year, and the changes of lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes and the differences among the three groups will be analyzed before and after treatment. The metabolomic changes of overweight/obese patients with type 2 diabetes before and after medication and the differences among the three groups will be analyzed. Explore the correlation between visceral fat content, glucose and lipid metabolism, inflammatory factors and other biochemical indicators and metabolomics.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years old
- •BMI≥24kg/㎡, or waist circumference: > 85cm (for male) or > 80cm (for female)
- •Has been diagnosed with type 2 diabetes mellitus
- •Good blood glucose control in recent three months: random blood sugar < 14mmol/L and HbA1c 6-9%
- •Not received any drugs affecting glucose and lipid metabolism or weight loss surgery in the past one month
排除标准
- •Abnormal weight gain caused by other endocrine diseases
- •Severe metabolic diseases, such as diabetic ketoacidosis, hypertonic hyperglycemia
- •Type 1 diabetes or other special types of diabetes
- •Used drugs affecting glycolipid metabolism in the past three months
- •Severe bleeding tendency that unable to complete venous blood collection
- •Patients with MRI contraindications
- •Severe renal insufficiency or severe liver insufficiency
- •Patients with advanced malignant tumors
- •Serious cardiovascular and cerebrovascular diseases
- •Rheumatic and immune diseases
- •Pregnant and lactating women
研究组 & 干预措施
Liraglutide group
Liraglutide is injected once a day.
干预措施: Liraglutide (Drug)
Semaglutide group
Semaglutide is injected once a week.
干预措施: Semaglutide (Drug)
Metformin group
Metformin is taken orally daily.
干预措施: Metformin (Drug)
结局指标
主要结局
Triglyceride
时间窗: The twelfth week of treatment
Lipid metabolism index
Lipoprotein
时间窗: The twelfth week of treatment
Lipid metabolism index
Blood glucose
时间窗: The twelfth week of treatment
Glucose metabolism index
Total cholesterol
时间窗: The twelfth week of treatment
Lipid metabolism index
Abdominal fat distribution
时间窗: The twelfth week of treatment
Use Magnetic resonance imaging-proton density fat fraction to measure fat accumulation in the liver, pancreas and abdomen.
Blood insulin
时间窗: The twelfth week of treatment
Glucose metabolism index
Weight
时间窗: The twelfth week of treatment
Measure fasting weight
次要结局
未报告次要终点
研究者
Jing Ma
Head of Endocrinology and Metabolism
RenJi Hospital