NCT05285397Unknown不适用
Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.
General Committee of Teaching Hospitals and Institutes, Egypt1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage Excess body weight loss
研究概览
简要总结
Our primary objective is to assess the effect of Liraglutide on weight loss in patients who have undergone secondary bariatric surgeries. We set out to assess if Liraglutide is a viable option to augment weight loss in said category.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergone primary bariatric surgery
- •Need secondary bariatric surgery due to either weight regain (regained weight to have BMI > 35) or medical associated diseases
排除标准
- •Prior use of GLP-1 agonist
- •Past history of pancreatitis
- •Personal or family history of medullary thyroid cancer
- •Pregnancy or lactation
- •Acute coronary syndrome
- •Hepatic or renal dysfunction
- •Active malignancy
研究组 & 干预措施
Liraglutide
Experimental
drug starts 6 weeks post-operative until 6 months SC injection dose starting 0.6 mg/day and weekly up titrated until 3.0 mg/day
干预措施: Liraglutide Pen Injector [Saxenda] (Drug)
结局指标
主要结局
Percentage Excess body weight loss
时间窗: 6 months
Percentage Total weight loss
时间窗: 6 months
次要结局
- Sleep apnea(6 months)
- Lipid profile(6 months)
- Comorbidities(6 months)
- Weight(6 months)
- BMI(6 months)
- HOMA-IR(6 months)
- HbA1C(6 months)
- Resolution of type 2 Diabetes Mellitus(6 months)
- Fasting Blood Glucose (FBG)(6 months)
- Blood pressure(6 months)
研究者
Mohamed Hany Ashour
Ass. Prof. of General surgery
General Committee of Teaching Hospitals and Institutes, Egypt
研究点 (1)
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