Behavioral and Pharmacological Treatments to Enhance Weight Outcomes after Metabolic and Bariatric Surgery

行为和药物治疗可增强代谢和减肥手术后的体重结果

• 批准号: 10452768
• 负责人: VALENTINA IVEZAJ
• 金额: $ 69.29万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-19 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10452768
• 关键词: Acute; Adult; Aftercare; Behavior Therapy; Behavioral; Body Weight decreased; Body mass index; Bupropion; Caring; Chronic; Clinical; Clinical Research; Combined Modality Therapy; Combined Pharmacological and Behavioral Treatment; Data; Dietary intake; Double-Blind Method; Eating Disorders; Economic Burden; Effectiveness; Evidence based treatment; FDA approved; Future; Gastrectomy; Gastric Bypass; Glucose; Glycosylated hemoglobin A; Guidelines; Health Care Costs; Individual; Insulin; Lipids; Longterm Follow-up; Mediator of activation protein; Medical; Metabolic; Modeling; Moods; Morbid Obesity; Naltrexone; Neck; Obesity; Operative Surgical Procedures; Outcome; Outcome Assessment; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Physical activity; Placebos; Procedures; Prospective Studies; Psychopathology; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Refractory; Risk Factors; Stratification; Subgroup; Testing; United States National Institutes of Health; Weight; Weight-Loss Drugs; bariatric surgery; base; burden of illness; cardiometabolic risk; cardiovascular risk factor; comorbidity; craving; depressive symptoms; design; effective therapy; effectiveness testing; follow up assessment; food craving; improved; obese patients; obesity risk; obesity treatment; patient oriented; placebo controlled study; primary outcome; psychosocial; symptomatology; treatment effect; weight loss intervention

Project Summary. Rates of obesity and severe obesity are expected to continue to rise to alarming levels. By 2030, over 51% of adults in the US are expected to have obesity with a 130% increase in severe obesity. These staggering rates and projected future increases are deeply concerning given the substantial disease and economic burden of obesity. As severe obesity rates continue to rapidly rise, the use of metabolic and bariatric surgeries (MBS) is expected to increase. MBS is the most effective treatment for severe obesity and results in impressive acute and long-term weight loss, as well as improvement of medical and psychosocial comorbidities. Yet, weight outcomes are markedly variable after MBS, suggesting that surgery alone is not enough for a sizeable subgroup with severe obesity. Weight regain after MBS is common and a major concern, particularly because weight regain is associated with recurring or even worsening medical comorbidities. Despite the need for ongoing obesity treatment after MBS due to the chronicity of obesity and risk for regain, there is little guidance as to what treatment(s) should be provided based on empirical data. In fact, no prospective studies or randomized controlled trials (RCTs) have examined the effectiveness of pharmacologic agents and very few (and limited) RCTs have examined behavioral weight loss (BWL) to enhance weight losses following MBS. Thus, rigorous RCTs combining pharmacological and manualized BWL treatment to enhance weight outcomes after MBS is an imperative next step to reduce personal and public health costs of obesity. To help fill this critical gap in the MBS field, the proposed RCT will test the effectiveness of a rigorous manualized BWL and a FDA-approved weight-loss agent (naltrexone+bupropion/NB), alone and in combination, for improvements in weight loss, cardiovascular risk factors, and psychosocial functioning. N=160 patients with obesity (BMI≥30 or ≥27 with a medical comorbidity) who underwent MBS and have suboptimal weight outcomes will be randomly assigned (double-blind) in balanced factorial (2 X 2) design, to one of four 24-week conditions: BWL+NB, BWL+Placebo, NB-only (No BWL), or Placebo-only (No BWL). Outcome variables were determined based on the leading rigorous weight loss RCTs for obesity with NB, NIH ADOPT guidelines, and conceptually-relevant variables for NB and BWL. Independent outcome assessments will determine outcomes after discontinuation of treatments through 18 months. The proposed RCT will provide important new clinical findings regarding the utility and effectiveness of pharmacotherapy and BWL for a rapidly growing obesity subgroup and will inform care models for managing chronic obesity to enhance outcomes after MBS. This will be the first RCT to 1) test any pharmacologic treatment for obesity after MBS; 2) examine BWL and NB, alone and in combination, for weight loss and associated features in patients who have undergone MBS; and 3) examine the durability of treatment effects from combined treatment modalities by including long-term follow-up assessments after treatment delivery.

项目摘要。 肥胖率和严重肥胖率预计将继续上升到令人震惊的水平。到2030年，超过51%的 预计美国成年人会患上肥胖症，严重肥胖症的发病率将增加130%。这些令人震惊的比率 考虑到严重的疾病和经济负担，预计未来的增长令人深感担忧 肥胖。随着严重肥胖率继续快速上升，代谢和减肥手术(MBS)的使用 预计会增加。MBS是治疗严重肥胖症的最有效的治疗方法，其疗效令人印象深刻 和长期减肥，以及改善医疗和心理社会并存。然而，重量 MBS后的结果明显不同，这表明仅有手术是不足以治疗相当大的 重度肥胖亚组。MBS后体重恢复是常见的，也是一个主要的担忧，特别是因为 体重恢复与复发甚至恶化的医学合并症有关。尽管需要 MBS后持续的肥胖治疗由于肥胖的慢性化和复发的风险，几乎没有指导意义 至于(S)应该提供什么治疗，这是基于经验数据。事实上，没有前瞻性研究或 随机对照试验(RCT)已经检验了药理学药物的有效性，而且很少有 (和有限的)随机对照试验检查了行为体重减轻(BWL)，以加强MBS后的体重减轻。 因此，严格的随机对照试验结合了药理学和手工化BWL治疗以提高体重结果 在MBS之后，下一步势在必行，以降低肥胖症对个人和公共健康的成本。帮助填补这一空白 作为住房抵押贷款证券化领域的关键空白，拟议的RCT将测试严格的手册BWL和 FDA批准的减肥剂(纳曲酮+安非他酮/NB)，单独或联合使用，可改善 体重减轻、心血管危险因素和心理社会功能。N=160名肥胖患者(体重指数≥为30或 患有医疗合并症的27岁的≥)接受了微创手术，但体重结果不佳的人将被随机 按平衡析因(2×2)设计分配(双盲)到四个24周条件之一：BWL+NB， BWL+安慰剂、只服用NB(不服用BWL)或仅服用安慰剂(不服用BWL)。结果变量的确定基于 美国国立卫生研究院领先的针对肥胖的严格减肥随机对照试验采用指南，并与概念相关 Nb和BWL的变量。独立的结果评估将决定停药后的结果 经过18个月的治疗。建议的随机对照试验将提供重要的新的临床发现 药物疗法和体重指数对快速增长的肥胖亚组的效用和有效性，并将告知 管理慢性肥胖症的护理模式以改善MBS术后的结果。这将是RCT到1)的第一次测试 MBS后对肥胖的任何药物治疗；2)单独和联合检查BWL和NB是否 接受MBS的患者的体重减轻和相关特征；以及3)检查 综合治疗方式的治疗效果，包括术后长期随访评估 治疗递送。