跳至主要内容
临床试验/NCT04809129
NCT04809129暂停不适用

Testing the Gravitostat in Humans: the Impact of a Weighted Vest in Patients Post Bariatric Surgery on Fat-free Mass Retention and Weight Loss

University College Dublin2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
40
试验地点
2
主要终点
Weight loss

研究概览

简要总结

The mechanisms regulating fat mass homeostasis are incompletely understood although recent animal and human trials would suggest that there is a leptin independent regulatory pathway which may play a role in weight control and maintenance. Although evidence would suggest that external loading in patients with obesity may promote body weight loss, this has not been explored in patients following bariatric surgery.

The aim of this study is to investigate the mechanisms regulating weight loss and the potential role of the 'gravitostat' in fat free mass retention in patients following bariatric surgery.

详细描述

The aim of the study is to investigate the mechanisms that regulate weight loss, particularly following bariatric surgery. Previous animal studies have suggested that there is an underlying regulatory process controlled by 'the gravitostat' which is an evolutionary adaptation responsible for weight control and maintenance. Studies exploring this concept in rodent models have suggested that artificially increasing the animal's weight with the implantation of weighted capsules results in greater weight loss in mice with obesity but does not affect those of normal weight. We will use weighted vests in patients following surgery to replicate this increased mechanical loading to determine whether a similar process occurs in humans. This will improve our understanding of the underlying processes regulating weight in patients with obesity and following bariatric surgery.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing bariatric surgery- Roux en Y gastric bypass or sleeve gastrectomy
  • Age 18-60
  • BMI >30kg/m2
  • Reporting regular physical exercise (>3 days/week)
  • Willingness to comply with the study protocol

排除标准

  • Sedentary lifestyle
  • Chronic pain that is constant and impairs the quality of life such as severe back, hip or knee pain
  • Reduced mobility requiring the use of a mobility aid
  • Undergoing revisional surgery
  • Concerns from the investigator that the participant will be unable to fully comply with the study protocol

结局指标

主要结局

Weight loss

时间窗: 1 year

Weight loss (kg)

Fat free mass retention

时间窗: 1 year

Fat free mass retention as measured using DEXA scan

次要结局

  • Changes in protein and inflammatory marker levels myostatin(1 year)
  • Changes in protein and inflammatory markers(1 year)
  • Changes in protein and inflammatory markers lipocalin-2(1 year)
  • Changes in protein and inflammatory markers IGF-1(1 year)
  • Changes in protein and inflammatory markers IL-6(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验