Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the "Gravitostat", Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Loss of lean mass at 1 monts and 3 months after bariatric surgery in patients undergoing "weight compensation" compared to a group of patients following a conventional approach (without gravitostat activation).
研究概览
简要总结
Due to its mechanical and metabolic functions, muscle loss leads to resistance to weight loss during caloric restriction, particularly in patients with obesity. The recent discovery of a "gravitational" homeostatic system, induced by an additional load to body weight, suggests the existence of a new weight control mechanism. Such a "gravitostat" would ensure a form of weight homeostasis mediated by afferent signals originating from osteocytes in response to gravity perception. This hypothesis, initially derived from animal studies, has more recently been tested in humans. It shows that "activation of the gravitostat" through artificial increases in body weight facilitates body weight reduction without affecting lean mass (LM). Therefore, this "gravitostat" could contribute to preserving LM despite the loss of fat mass , whereas its decline may compromise muscle mass and function after bariatric surgery, despite undeniable improvements in comorbidities.
The present study aims to reduce the "metabolic load" (i.e., decreasing insulin resistance and inflammation) to promote muscle protein anabolism, while maintaining the "mechanical load" (by preserving initial body weight during weight loss induced by bariatric surgery) in order to activate the "gravitostat" and preserve muscle mass and function.
Currently, there are no clear recommendations or strategies to prevent muscle loss in patients who have undergone bariatric surgery. This simple concept, applied during drastic muscle loss, should help improve muscle health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants
- •Aged between 18 and 60 years
- •Planned for bariatric surgery, such as sleeve gastrectomy
- •Able to give informed consent to participate in research
- •Affiliated to a social security scheme
排除标准
- •Women weighing 170 kg or more
- •Inability to move around independently.
- •Participants with a spinal pathology.
- •Pregnant or breast-feeding women.
- •Inability to comply with protocol recommendations.
- •Adults under legal guardianship (curatorship, guardianship, deprivation of liberty, patients benefiting from a judicial protection measure or safeguard of justice).
- •Refusal to participate.
研究组 & 干预措施
Gravitostatic group (with mechanical load involving the use of a weighted vest)
干预措施: maintaining mechanical load (Other)
Non-gravitostatic group (control group)
结局指标
主要结局
Loss of lean mass at 1 monts and 3 months after bariatric surgery in patients undergoing "weight compensation" compared to a group of patients following a conventional approach (without gravitostat activation).
时间窗: 1 month and 3 months after bariatric surgery
lean mass measurement with dual energy x-ray absorptiometry, DXA
次要结局
- Changes from baseline on bone architecture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Loss of lean mass at 6 months after bariatric surgery in patients undergoing "weight compensation" compared to a group of patients following a conventional approach (without gravitostat activation).(6 months after bariatric surgery)
- Change from baseline on waist circumference at 1 month (M1), 3 months (M3), and 6 months (M6)(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on hip circumference at 1 month (M1), 3 months (M3), and 6 months (M6)(1 month (M1), 3 months (M3), and 6 months (M6))
- Changes in muscle function (Handgrip strength test) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Changes in muscle function (Short Physical Performance Battery (SPPB)) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Changes from baseline on muscle architechture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Changes from baseline on bone architechture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on weight at 1 month (M1), 3 months (M3), and 6 months (M6)(1 month (M1), 3 months (M3), and 6 months (M6))
- Changes in muscle function (6-minute walk test (TM6)) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on blood glucose at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on cholesterol at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on triglycerides at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on insulin levels at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on CRP at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on urinary creatinine at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on Plasma, serum, and urinary biomarkers(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect on Maximal strength(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect on Food intake(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on Nitrogen balance(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect on Quality of life using a visual analog scale(1 month (M1), 3 months (M3), and 6 months (M6))
- Change from baseline on BMI at 1 month (M1), 3 months (M3), and 6 months (M6)(1 month (M1), 3 months (M3), and 6 months (M6))
- Muscle mass in the arms and legs at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect on Food preferences and reward(1 month (M1), 3 months (M3), and 6 months (M6))
- To assess the effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on energy expenditure(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect on substrate utilization during an incremental submaximal walking exercise at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on energy expenditure(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect on perceived exertion during an exercise (Borg scale)(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect of heart rate(1 month (M1), 3 months (M3), and 6 months (M6))
- Effect of weight compensation on spontaneous physical activity using accelerometry(on day 4 or the day after returning home following surgery, and then at 1 month (M1) and 3 months (M3) after surgery.)
- Study the longitudinal evolution of weight every week until M1, then every 2 weeks until M3 for the experimental group.(every week until 1st month, then every 2 weeks until 3rd month after bariatric surgery)
- Study the longitudinal evolution of BMI every week until M1, then every 2 weeks until M3 for the experimental group.(every week until 1st month, then every 2 weeks until 3rd month after bariatric surgery)
- Tolerance with wearing the vest for the experimental group(from bariatric surgery to the end at 3 months)
- Compliance with wearing the vest for the experimental group(from bariatric surgery to the end at 3 months)