Resting Metabolic Rate: is a Predictor Weight Regain?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in body composition
研究概览
简要总结
he increasing prevalence of obesity in developed countries has also reached Brazil in the last two decades. Conventional treatments are not efficient to sustained weight loss and in some cases, weight reduction in individuals refractory to these methods. Bariatric surgery has been considered as the most efficient long-term treatment. However, numerous studies have reported weight regain in approximately 20% of patients, from the second year of surgery. The objective of this study is to analyze the changes in resting metabolic rate and body composition before, 6 and 36 months after weight loss and its relation to late weight regain. 48 adults of both sexes, above 18 years, will undergo bypass performed the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP. Patients over 60 years, undergoing revision surgery and other surgical techniques will be excluded. The body weight (kg) will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Excess weight (kg): difference in preoperative weight versus ideal weight considered for weight for BMI 25kg/m2. Weight loss (kg): pre-surgery weight difference in relation to the lowest weight reached after 18 months. Percentage of excess of weight loss is difference of weight loss in relation to overweight, used as an indicator of success of surgery. Fat mass (%, kg) and fat-free mass (%, kg) will be obtained by electrical bioimpedance 230, 2.0. For resting metabolic rate, the values of VO2 and VCO2 will be collected by indirect calorimetry using Ultima CPX metabolic analyzer. The daily energy expenditure (kcal/day) will be calculated by the Weir equation.
keywords: obesity, resting metabolic rate, body composition analysis, bariatric surgery.
详细描述
INTRODUTION The increasing prevalence of obesity in developed countries has also reached Brazil in the last two decades and is now among the ten countries with the largest number of obese people in the world1.
According to the Vigilance Survey of Risk Factors and Protection for Chronic Diseases by Telephone Inquiry (Vigitel, 2014), overweight in Brazil affects 49.1% of women and obesity affects 18.2% of male population2.
The most recent data on the spread of the disease in the world present alarming numbers. It is estimated that 1.9 billion adults around the world are overweight and more than 600 million are considered obese3.
Characterized by excess of body fat, obesity is a chronic disease of multifactorial origin that is difficult to handle when it reaches body mass index (BMI) above 40 kg/m2. In these cases, conventional treatments such as restriction food intake, medication and monitored physical exercise are not efficient to sustained weight loss and in some cases, weight reduction in individuals refractory to these methods4.
For those individuals who do not respond to these treatments for more than two years and BMI ≥35 kg/m2 with comorbidities such as sleep apnea, Type 2 Diabetes Mellitus, hypertension, dyslipidemias, depression, asthma, infertility among others, surgery has been considered as the most efficient long-term treatment. Surgical treatment results in loss of between 20 and 40% of the initial weight or between 60 and 80% of the excess weight, as well as higher rates of remission of Type 2 Diabetes and Metabolic Syndrome, improvement in the quality of life and reduction in use hypoglycemic, antihypertensive and hypolipidemic drugs5-7.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both sexes,
- •Above 18 to 60 years
排除标准
- •Adult patients over 60 years old,
- •patients undergoing revision surgery and other surgical techniques will be excluded.
结局指标
主要结局
Changes in body composition
时间窗: Before, 6 months and 36 months after bariatric surgery
This will be evaluated fat mass (kg, %) and fat-free mass (kg,%) by electrical bioimpedance before and after 6 and 36 months of bariatric surgery.
Changes in resting metabolic rate
时间窗: Before, 6 months and 36 months after bariatric surgery
This will be evaluated by indirect calorimetry before and after bariatric surgery: kcal per day and per kilogram fat free mass.
Late weight regain
时间窗: 18 months of bariatric surgery
This will be evaluated considering the lowest weight (in kilos) reached after 18 months of bariatric surgery
次要结局
未报告次要终点
研究者
Roberto de Cleva
Principal investigator
University of Sao Paulo General Hospital