SEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 14
- 主要终点
- Weight trends in patients included in the SEMASEARCH cohort at initiation and 12 months of treatment with WEGOVY®.
研究概览
简要总结
The aim of the SEMASEARCH project is therefore to constitute a retrospective cohort, from the available data on patients already included in the ATUc/AP2, and prospective, on new patients who will initiate treatment according to the AP2 PUT, of 15 Specialized Obesity Centers in order to describe the effect of WEGOVY® treatment in this population. Thanks to a high phenotyping, subpopulations of interest will be identified to know the specifics of the effect of the treatment in these subgroups of interest. Secondary analyses will aim to look for clinical or biological biomarkers of success in the weight response to WEGOVY® in the entire prospective cohort, but also in specific subpopulations.
In summary, the analysis of the entire SEMASEARCH cohort and sub-populations of interest will be based on a complete clinical phenotyping of patients (included in retrospective and prospective studies), completed by ad hoc questionnaires and associated with biological markers (prospective) partly collected within the framework of the WEGOVY® AP (glycaemia, hepatic assessment, lipid assessment ) and partly from a biobank to test specific hypotheses (predictive role of leptin sensitivity, insulin sensitivity level, plasma level of endocannabinoids, etc.).
In addition, approaches using artificial intelligence (AI), notably machine learning, will make it possible to determine the variables or combination of variables that are most predictive of the weight response to treatment with WEGOVY® in the largest population. Indeed, individual weight loss in response to weight loss strategies is highly variable, whether purely related to lifestyle changes or pharmacological. Well-known factors associated with the ability to lose weight include adherence to lifestyle change, gender, age and specific medications. However, after controlling for these factors, differences in weight loss appear to persist in response to different interventions including pharmacological ones. Adaptation to energy deficit involves complex feedback mechanisms, and inter-individual differences are likely to arise from a range of poorly defined factors. Thus, a better understanding of the factors involved in inter-individual variability in response to WEGOVY® will help guide more personalised approaches to the management of these patients. AI techniques will be used to determine which combination of clinical or biological variables are most predictive of weight response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Weight trends in patients included in the SEMASEARCH cohort at initiation and 12 months of treatment with WEGOVY®.
时间窗: At initiation of treatment and 12 month of treatment
Weight change between treatment initiation and 12 months after (greater than or equal to 10%)
次要结局
- Proportion of responders at Month 12(12 months)
- Change in binge eating and eating behavior(baseline, 6 and 12 months)
- Change in sleep behavior based on Munich ChronoType Questionnaire (MCTQ)(baseline, 6 and 12 months)
- Change in quality of life(baseline, 6 and 12 months)
- Change in physical activity based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF)(baseline, 6 and 12 months)
- Change in gastrointestinal symptoms based on the reduced Gastrointestinal Quality of Life Index (GIQLI)(baseline, 6 and 12 months)
- Change in anxiety and depression based on Hospital Anxiety and Depression Scale (HADS)(baseline, 6 and 12 months)
- Evolution of metabolic comorbidities - Change in fasting glucose level (mg/dL)(baseline, 6 and 12 months)
- Number of participants with treatment-related adverse events reported in the eCRF at 6 and 12 months(6 and 12 months)
- Change in body composition - Change in fat mass percentage measured by Dual-Energy X-ray Absorptiometry (DXA)(baseline, 6 and 12 months)
- Change in muscle strength based on chair stand test(baseline, 6 and 12 months)
- Difference in lean mass between sarcopenic and non-sarcopenic patients(baseline, 6 and 12 months)
- Change in body weight in each subpopulation(baseline, 6 and 12 months)
- Proportion of responders by subpopulation at Month 12(baseline and 12 months)
- Change in binge eating disorder symptoms in binge eating disorder subgroup(baseline and 12 months)
- Change in prevalence of extreme obesity(baseline and 12 months)
- Change in psychotropic medication use at 12 months in patients on psychotropic medication(baseline and 12 months)
- Evolution of metabolic comorbidities - Change in liver enzymes (ALT and AST - U/L)(Baseline, 6 months, and 12 months)
- Evolution of metabolic comorbidities - Change in lipid profile (total cholesterol, HDL, LDL, triglycerides - mg/dL)(Baseline, 6 months, and 12 months)
- Change in body composition - Change in lean body mass measured by Bioelectrical Impedance Analysis (BIA)(Baseline, 6 months, and 12 months)
- Difference in muscle strength between sarcopenic and non-sarcopenic patients(Baseline, 6 months, and 12 months)
- Change in eating behavior based on Dutch Eating Behavior Questionnaire (DEBQ)(Baseline, 6 months, 12 months)
- Change in hunger based on Hunger Score(Baseline, 6 months, 12 months)