Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to the Modification of Body Composition and Bone Turnover After Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery.
研究概览
简要总结
By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality.
详细描述
To date, there are no studies in scientific literature aimed at identifying the hormonal mechanisms that could contribute to increased bone turnover in patients undergoing bariatric surgery. All randomized controlled trials conducted to date have focused on nutritional factor deficiency (vitamin D3, calcium and protein), mechanical unloading and reduction of adiposity at the bone marrow level.
By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •Age ≥ 18 and ≤ 60 years.
- •BMI (Body Mass Index: expressed as weight ratio in kg/height in m2) ≥ 35 kg/m2 with comorbidities or BMI ≥ 40 Kg/m2 without comorbidities.
- •Absence of diagnosis of primary obesity.
- •Absence of medical-psychiatric contraindications.
- •Previous diet therapy and/or pharmacological history verified.
- •Signing of the informed consent for the study.
- •Patients who are clinical candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
排除标准
- •Presence of chronic diseases of the digestive system, such as chronic intestinal diseases, malabsorption syndrome, diverticulosis of the colon.
- •Current pregnancy and/or breastfeeding via self-declaration.
- •Subjects suffering from endocrine pathologies (e.g. Cushing's disease, uncontrolled thyroid disease).
- •Presence of known renal insufficiency or creatinine levels above 1.8 mg/dl and eGFR < 60 ml/min.
- •Presence of chronic liver disease or ALT and AST levels above two standard deviations from normal levels.
- •Presence of malignant pathology.
- •Alcohol or drug abuse.
- •Previous bariatric surgery.
- •Severe psychological-psychiatric disorders.
- •Difficulty adhering to the protocol due to language barriers or other reasons.
结局指标
主要结局
Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery.
时间窗: Two timepoints: pre-admission before bariatric surgery and 12 months after.
Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery by evaluating the circulating levels of gastro-entero hormones, adipokines and hormones associated with anabolism of muscle and bone tissue.
次要结局
- Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods.(Two timepoints: pre-admission before bariatric surgery and 12 months after.)