Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part A)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Total hip T-Score measured with dual-energy x-ray absorptiometry
研究概览
简要总结
The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.
详细描述
Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: data on alterations in bone health are missing,
The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-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
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received laparoscopic sleeve gastrectomy (LSG) or laparoscopic gastric bypass (LRYGB) ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.
排除标准
- •LSG or LRYGB as a secondary bariatric procedure (e.g. after gastric banding), patients receiving secondary bariatric operation after LSG resp LRYGB (e.g. biliopancreatic diversion), pregnancy (due to radiation exposition)
研究组 & 干预措施
Gastric Bypass
Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
干预措施: DEXA (= Dual-energy x-ray absorptiometry) (Diagnostic Test)
Sleeve gastrectomy
Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
干预措施: DEXA (= Dual-energy x-ray absorptiometry) (Diagnostic Test)
结局指标
主要结局
Total hip T-Score measured with dual-energy x-ray absorptiometry
时间窗: 5-7 years after bariatric surgery
measured score will be compared to reference score for this age
次要结局
- Total vertebral T-Score measured with dual-energy x-ray absorptiometry(5-7 years after bariatric surgery)
- fracture risk assessed by FRAX score(5-7 years after bariatric surgery)
- plasma concentration of C-terminal telopeptide (CTX)(5-7 years after bariatric surgery)
- plasma concentration of vitamin D3(5-7 years after bariatric surgery)