Metabolic Changes of Fat and Bone Tissue After Radical Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Changes in serum levels of osteomarkers
研究概览
简要总结
Literature data clearly demonstrate that treatment of obese patients is very expensive, long and achieve weight loss may not be permanent, and regardless of whether the treatment dominated diet therapy, physical activity, or pharmacotherapy. Experience of the last decade has shown that after surgical interventional treatment of obesity occurs not only long-term (10 years and over) weight loss of 35-40%, but also an important endocrine changes.
In recent years, it was discovered a number of signaling molecules produced by adipose tissue, whose physiological significance beyond the general metabolic aspects organism. The fat is therefore currently understood as an endocrine organ whose hormones modulate the function of many systems, including the skeleton. These hormones include the adipokines that modulate metabolism skeleton as at tissue level (Leptin, Adiponectin) and indirectly - by activation of neurohumoral hypothalamic centers - Leptin.
Studying endocrine interactions between adipose tissue and bone is a highly topical issue. This mutual communication is a homeostatic feedback system in which adipokines and molecules secreted by osteoblasts and osteoclasts are the connecting link active axes fat - bone tissue. However, the mechanisms of this axis remain largely unknown.
详细描述
Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone metabolism. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. Because restrictive procedures such as LSG do not involve bypassing segments of small bowel where micronutrient absorption takes place, fewer metabolic disturbances are expected than with other surgical techniques.
The observed changes in bone metabolism and status in post-bariatric surgery patients potentially involve several mechanisms, including reduced absorption of essential nutrients, diminished calcium absorption leading to secondary hyperparathyroidism, poor vitamin D absorption and restricted energy delivery. In addition, body weight protects against osteoporosis via the bone-strengthening effects of long-term weight bearing. However, long-term decreases in bone mineral density in patients who have undergone successful bariatric surgery are an unexpected, negative effect of this type of therapy.
In the study, parameters of fat and bone tissue and body composition changes are assessed in groups of bariatric patients after LSG, gastric plication and intragastric balloon treatment. Other anticipated benefits of the study treatment include improving the quality of life of. lt will also lead to the introduction of new processes, materials and methods. lt is also possible to expect shortening of the hospital stay, decrease in postoperative morbidity, and the possibility to perform the procedure on an outpatient basis.
The study has been designed as a prospective study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and has been approved by the Ethical Committee of the Faculty of Medicine, University of Ostrava.
The patients enrolled in the study are followed for the period of twelve months. Timetable of the study procedures and controls:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)
排除标准
- •Thyroid disease
- •Diseases of the digestive system associated with disorders of intestinal absorption
- •History of corticosteroid therapy in the past 12 months
研究组 & 干预措施
Laparoscopic sleeve gastrectomy
Patients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy.
干预措施: Laparoscopic sleeve gastrectomy (Procedure)
Laparoscopic gastric plication
Patients undergoing bariatric surgery procedure of laparoscopic gastric plication.
干预措施: Laparoscopic gastric plication (Procedure)
Intragastric balloon
Patients undergoing bariatric surgery procedure with intragastric balloon implantation.
干预措施: Intragastric balloon (Procedure)
Intragastric balloon
Patients undergoing bariatric surgery procedure with intragastric balloon implantation.
干预措施: Intragastric balloon implantation (Device)
结局指标
主要结局
Changes in serum levels of osteomarkers
时间窗: 18 months
To analyze the dynamics of changes in serum levels of usual panel of osteomarkers in adults after bariatric treatment of malignant obesity (BMI\> 35). The following serum levels markers of bone resorption and formation will be assessed: CTx, P1NP, ALP, RANKL, FGF 23, Osteocalcin, Osteopontin and vitamin D2 and D3. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).
SF-36 Questionnaire evaluation
时间窗: 18 months
Evaluation of effects of different types of bariatric interventions on quality of life will be performed using the SF-36 questionnaire. Improvement from baseline quality of life as measured by standardized SF-36 patient questionnaire intended to measure the patient health status.
IWQOL Questionnaire evaluation
时间窗: 18 months
Evaluation of effects of different types of bariatric interventions on quality of life will be performed by using the IWQOL questionnaire. Improvement from baseline quality of life as measured by standardized IWQOL patient questionnaire (http://www.qualityoflifeconsulting.com/iwqol-lite.html) intended to measure the patient health status.
Changes in serum levels of adipose tissue hormones
时间窗: 18 months
To analyze the dynamics of changes in serum levels of adipose tissue hormones (Leptin, Adiponectin) in adults after bariatric treatment of malignant obesity (BMI\> 35). Points of measurements: before the planned intervention and then in intervals of 3, 6, 12, and 18 months after procedure.
Changes in serum levels of lipids
时间窗: 18 months
To analyze the dynamics of changes in serum levels of lipids in adults after bariatric treatment of malignant obesity (BMI\> 35). In the study, serum concentrations of the following lipids will be measured: tricylglycerols, total cholesterol, high-density lipoprotein, low-density lipoprotein cholesterol, Apo D and Apo E. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).
次要结局
- Long-term weight reduction assessment in kgs(18 months)
- Effectiveness evaluation(18 months)