The Timing for Liraglutide in Patients Remaining Obese at 6 Months After Metabolic Surgery: an Observational Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in %TWL from baseline to endpoint across patient groups
研究概览
简要总结
The goal of this clinical trial is to compare the weight loss and metabolic benefit in patients remaining obesity at 6 months after metabolic surgery. The main questions it aims to answer are:
[primary hypothesis 1] Whether liraglutide benefits weight loss when it is initiated early after metabolic surgery.
[primary hypothesis 2] Whether weight loss and metabolic benefits are greater when linaglutide is initiated in patients who are obese at 6 months after metabolic surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients 6 months after metabolic surgery;
- •18 years ≤ age ≤ 65 years;
- •Body Mass Index (BMI) ≥ 28 kg/m^2
排除标准
- •allergy to liraglutide, severe hepatic or renal impairment (eGFR <60 mL/min/1.73 m² or ALT/AST ≥3× ULN)
- •history of medullary thyroid carcinoma, MEN-2 or other malignancies
- •pancreatitis or severe gastrointestinal disease, pregnancy or lactation
- •use of anti-obesity drugs or other interventional trials within 3 months or major uncontrolled illness
- •Patients were discontinued if withdrawn, intolerant, lost to follow-up, or developed severe adverse events.
研究组 & 干预措施
control group
Receive guidance on diet and exercise throughout the program, without the use of drugs
干预措施: Diet and exercise guidelines (Behavioral)
Liraglutide 6 month group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 6 months.
干预措施: Liraglutide injection (Drug)
Liraglutide 6 month group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 6 months.
干预措施: Diet and exercise guidelines (Behavioral)
Liraglutide 9 month group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 3 months of enrollment.
干预措施: Liraglutide injection (Drug)
Liraglutide 9 month group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 3 months of enrollment.
干预措施: Diet and exercise guidelines (Behavioral)
Liraglutide 12 month group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 6 months of enrollment.
干预措施: Liraglutide injection (Drug)
Liraglutide 12 month group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 6 months of enrollment.
干预措施: Diet and exercise guidelines (Behavioral)
结局指标
主要结局
Change in %TWL from baseline to endpoint across patient groups
时间窗: 48 weeks from enrollment
%TWL = (\[baseline weight - weight at follow-up\]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the percentage of weight loss from the baseline. The mean and standard deviation of %TWL were calculated for subjects within each group. Subsequently, intergroup comparisons were performed to calculate p-values. If p \< 0.05, pairwise comparisons were further conducted. Based on the final results, the differences in weight loss among groups were evaluated.
次要结局
- Change in BMI from baseline to endpoint across patient groups(48 weeks from enrollment)
- Change in body composition from baseline to endpoint across patient groups(48 weeks from enrollment)
- Changes in blood pressure from baseline to endpoint(48 weeks from enrollment)
- Changes in fasting blood glucose from baseline to endpoint(48 weeks from enrollment)
- Change in HbA1c from baseline to endpoint across patient groups(48 weeks from enrollment)