Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evolution of the excess of weight loss % (EWL%) after bariatric surgery.
研究概览
简要总结
The prevalence of obesity in Spain is about 21.6%. The discouraging results provided by dietary treatment, together with the lack of funding for pharmacological treatment, have led to the progressive use of bariatric surgery (CB). Besides weight loss, CB associates a beneficial effect on metabolic comorbidities. However, 25-30% of operated patients present a weight response considered inappropriate, they do not resolve their comorbidities and/or present a weight-regain shortly after surgery. Therefore, predictive strategies are necessary to allow a correct selection of obese patients who are candidates for CB.
The main hypothesis of the study is that various factors such as psychopathological profile, body composition and metabolic alterations related to morbid obesity can influence the response to bariatric surgery.
详细描述
The investigators have designed a prospective study in which 200 consecutive patients from the outpatient clinic of the Morbidly Obesity Unit of the Vall d'Hebron Hospital will be included, meeting criteria for bariatric surgery (with BMI> 40 kg / m2 or BMI> 35 kg /m2 in the presence of comorbidities) and will undergo surgery in the investigator's center between September 2018 and September 2019. All patients will undergo (baseline, month, 6, 12 and 24 month): complete clinical history, analysis complete biochemistry, 2 blood samples will be extracted to study metabolomics, stool sample for microbiota study, bioimpedance for the study of body composition, determination of AGEs in the skin and lens, cognitive function assessment, retinal function assessment by microperimetry and they will be asked to complete several specific questionnaires for the evaluation of the psychopathological profile and the dietetic survey.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients fulfilling criteria for bariatric surgery (BS).
- •Signed informed consent fir the BS and the study.
- •Previous accomplishment of the preoperative protocol for the BS at our site.
- •undergo BS between September 2018 and December 2019
- •Able to read and understand the specific questionnaires.
排除标准
- •Any contraindication for the bariatric surgery.
- •Impossibility to follow-up at our site (eg: patients from outside out community).
结局指标
主要结局
Evolution of the excess of weight loss % (EWL%) after bariatric surgery.
时间窗: 24 month
- Excess of weight loss % (EWL%) will be calculated using the following formula: pre-bariatric surgery weight (kg)-visit weight (kg)/pre-bariatric surgery weight (kg)- ideal weight (for BMI 25) (kg) x 100%. Changes in EWL% will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.
Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS).
时间窗: 24month
For the assessment of the evolution after bariatric surgery the investigators will use the body mass index parameter (BMI), calculated with the following formula: Body mass index (BMI) will be calculated as weight (kg)/height (m2). Changes in BMI, will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.
Evolution of the total weight loss after bariatric surgery
时间窗: 24 month
-Total weight loss (TWL) will be calculated as: pre-bariatric surgery weight (kg)- visit weight (kg). Changes in TWL will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.
次要结局
- Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry.(24 month)
- Evaluation of neuropsychological scores before and after bariatric surgery: eating attitudes(24month)
- Evaluation of neuropsychological scores before and after bariatric surgery: Beck Depression Inventory (BDI)(24month)
- Evaluation of neuropsychological scores before and after bariatric surgery: Sheehan Disability Inventory (SDI).(24 month)
- Evaluation of neuropsychological scores before and after bariatric surgery: ROTTER´s locus of control scale.(24month)
- Evaluation of neuropsychological scores before and after bariatric surgery: WPAI (working productivity questionnaire).(24month)
- Evaluation of the Advanced Glycation End products (AGEs) before and after bariatric surgery.(24 month)
- Evaluation of neuropsychological scores before and after bariatric surgery:The Bariatric Analysis and Reporting Outcome System (B.A.R.OS).(24month)
- Evaluation of the utility of the retinal function evaluation in the detection of cognitive disfunction before and after bariatric surgery(24 month)
- Evaluation of neuropsychological scores before and after bariatric surgery: Attention-Deficit Hyperactivity Disorder (ADHD)(24month)
- Evaluation of neuropsychological scores before and after bariatric surgery: Zuckerman-Kuhlman Personality Questionnaire (ZKPQ).(24month)
- Evaluation of neuropsychological scores before and after bariatric surgery: COPE- stress management strategies.(24month)
- Evaluation of neuropsychological scores before and after bariatric surgery: YALE food addiction.(24month)
- Evaluation of neuropsychological scores before and after bariatric surgery: The State-Trait Anxiety Inventory (STAI).(24month)
- Evaluation of the congnitive function before and after bariatric surgery(24 month)
研究者
Andreea Ciudin
Head of the Morbid Obesity Unit and Clinical Trials Department
Hospital Universitari Vall d'Hebron Research Institute