Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Pulmonary function tests
研究概览
简要总结
The purpose of this study is to evaluate the effects of intragastric balloon on bone, metabolic and respiratory parameters in 50 patients with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •metabolic syndrome (IDF criteria)
排除标准
- •menopause
- •older than 50 years
- •diabetes mellitus
研究组 & 干预措施
Intragastric balloon
Patients submitted to six-month intragastric balloon
干预措施: Silimed Intragastric balloon (Device)
结局指标
主要结局
Change in Pulmonary function tests
时间窗: Baseline and 6 months
Pulmonary function tests consiste of spirometry, body plethysmograph, diffusing capacity for carbon monoxide (DLco), and respiratory muscle strength. Measurements are conducted using the Collins Plus Pulmonary Function Testing Systems (Warren E. Collins, Inc., Braintree, MA, USA).
Change in bone microarchitecture
时间窗: Baseline and 6 months
Bone microarchitecture by high-resolution peripheral quantitative computed tomography
Change in lipid profile
时间窗: Baseline and 6 months
Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol
Change in bone mineral density and body composition
时间窗: Baseline and 6 months
Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)
Change in fasting and postprandial glucose
时间窗: Baseline and 6 months
次要结局
未报告次要终点
研究者
Miguel Madeira
Principal investigator
Universidade Federal do Rio de Janeiro