Effectiveness of the Use of External Body Weight in the Regulation of Body Weight, Body Composition and Analytical Parameters in Adults With Grade II and III Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
Obesity is a growing problem in industrialized societies. This condition is associated with an increase in metabolic and cardiovascular diseases. Its cause is multifactorial, influenced by the environment, excessive calorie consumption, insufficient physical activity, sedentary lifestyle and alterations in energy metabolism.
In this context, the hormone leptin, responsible for regulating appetite and body weight, presents resistance in people with obesity, altering the metabolic balance. Recent research has explored the concept of the "gravitostat", a system that responds to the mechanical stimulus of standing upright, as a promising approach in the regulation of body weight. Animal and human studies have shown positive results in weight loss and body recomposition using this system. However, more research is needed to evaluate the clinical applicability and effectiveness of the gravitostat in the management of obesity.
For this reason, the present study is proposed, with a prospective longitudinal controlled design in the use of external body weight (where the patients are their own control: intrasubject controlled study) during 4 weeks, with a previous control period of 4 weeks and a follow-up of 4 weeks. The proposed objectives are to analyze the effectiveness of the use of external weight in the regulation of body weight, body composition and analytical parameters in people with grade II and III obesity. In this way, to analyze the clinical applicability of the gravitostat in the management of patients with this metabolic pathology.
详细描述
BACKGROUND Obesity is one of the most prevalent and booming health and social problems in recent decades in industrialized societies. Obesity rates in European countries such as the United Kingdom, Germany, France and Spain fluctuate between 23 and 29% in the adult population, according to the World Health Organization (WHO). These values increase to 42.4%, 27% and 31% in the United States, Canada and Australia, respectively, considering data from the last 5 years from the main health agencies of these countries, making it a social and public health problem.
The etiopathogenesis of this condition is multifactorial; the obesogenic characteristics of the environment can influence gene expression conditioning the development of obesity. Increased caloric intake, influenced by high-fat diets (Westerns' diet), the absence or insufficiency of physical activity and alterations in energy metabolism seem to be the three fundamental factors contributing to the development of obesity. Moreover, these factors seem to play a major role in the development of other metabolic entities such as hypertension, dyslipidemia and insulin resistance or type II diabetes, which, together with central obesity, make up the metabolic syndrome. This clinical entity doubles the risk of coronary and cerebrovascular disease, increases the risk of diabetes fivefold, and increases all-cause mortality by 50%. In parallel to the risk factors listed above, some studies highlight the role of a sedentary lifestyle as a factor independent of physical activity in contributing to the development of metabolic pathology. Not only the absence of low, moderate or high intensity physical activity has been correlated with the development of metabolic syndrome, but also the increase in time spent in sedentary activities, with an odds ratio of 2.38.
These intrinsic and extrinsic factors seem to interact and condition each other, altering homeostatic and physiological processes in obese individuals.
Since its discovery and description in the 1990s by Friedman leptin has been the most important hormonal factor in the regulation and control of caloric intake and metabolism, and consequently of body weight and composition. Its peripheral production at the level of white fat tissue and its hypothalamic effects (decrease in orexic neuronal activity and conditioning of dopaminergic reward circuits) condition the individual's response to food, regulating satiety and intake.
Evidence shows that this mechanism is altered in people with obesity where excessive leptin production, due to increased concentrations of fat tissue, and consequently high serum concentrations, condition central and peripheral sensitivity to this hormone, generating, in the long run, lower response efficiency, giving rise to the term "leptin resistance ". This resistance seems to modify the hypothalamic satiety signal, as well as the dopaminergic circuits associated with food intake,predisposing to the appearance or increase of metabolic pathology, especially obesity. This dysregulation in caloric intake appears without alterations in the production and function of ghrelin, a hormone produced in the stomach associated with hunger.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •BMI (≥35)
- •Compliance at intervention delivery.
排除标准
- •Chronic pathology that may hinder the performance of the intervention
- •Chronic pain
- •Regular consumption of pharmacology or supplementation that affects body weight
- •Inability to perform any physical activity or high risk of suffering adverse effects from the interventibariatric-metabolic surgery
- •Reduced mobility
- •Changes of 5kg or more in the last 3 months
- •Drastic changes in lifestyle habits in the last 3 months (physical activity, eating habits, nicotine or alcohol consumption)
- •Apparent risk of not being able to complete the study intervention (at the principal investigator's discretion)
- •Pregnancy
结局指标
主要结局
Body weight
时间窗: From enrollment to the end of treatment at 12 weeks
Measured fasting weight by electronic scale (BC-545N Tanita)
次要结局
- Nutritional state(From enrollment to the end of treatment at 12 weeks)
- Grip Strength(From enrollment to the end of treatment at 12 weeks)
- Lower Extremity Strength(From enrollment to the end of treatment at 12 weeks)
- Activity state(From enrollment to the end of treatment at 12 weeks)
- Absolute frequency of patients reporting adverse effects(From week 4 to the end of treatment at 12 weeks)
- Age(Baseline)
- Sex(Baseline)
- Height(Baseline)
- Body Mass Index(Baseline)
- Body compostiton(From enrollment to the end of treatment at 12 weeks)
