Evaluation of Endoscopic Sleeve Gastroplasty (ESG) as an Alternative Weight Loss Strategy for Patients With Obesity Discontinuing GLP-1 Receptor Agonists Due to Intolerance or Ineffectiveness: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Percent total body weight loss (TBWL) at 1 year from baseline
研究概览
简要总结
This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight loss.
详细描述
This retrospective cohort study includes collection of data from medical records for consecutively treated patients undergoing treatment for weight loss following GLP-1 discontinuation. Weight loss treatment is either ESG with OverStitch™ OverStitch NXT™ or matched timeframe controls who participated in a lifestyle modification program for weight loss management.
Subjects will be enrolled in a 2:1 ratio (ESG: Lifestyle modification)
Patients are required to have the following visits for weight loss management:
- Completed initial consultation visit (baseline) prior to initiation of weight management program with documented GLP-1 history and reason for discontinuation
- Initiation of weight loss management no earlier than August 2021
- A minimum of two weight loss management visits, defined as performed by the physician that is managing the weight loss program and/or an affiliated weight loss specialist, completed at 1, 3, 6, or 9 months from the initiation of weight loss management
- Completed 1-year weight loss management visit (as defined above)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years)
- •BMI ≥30 kg/m² and ≤ 50 kg/m2
- •Discontinued GLP-1 therapy for weight loss (semaglutide and tirzepatide only) for intolerance or suboptimal weight loss (<5% TBWL after 3 months at maximally tolerated dose)
- •Initiation of weight loss management no earlier than August 2021
- •Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
- •Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment
排除标准
- •Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
- •History of GLP-1 medication for a reason other than weight management
- •Had bariatric surgery or an endoscopic procedure for weight loss treatment other than ESG with OverStitch™ or OverStitch NXT™ within 1 year of starting weight loss management
- •Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
- •Had another weight loss treatment during the 1-year follow-up reported during this study. Weight loss treatment includes but is not limited to appetite suppressants, anti-obesity medications, plastic surgery or body contouring procedures.
- •Pregnancy during the 1 year following initiation of weight loss management
研究组 & 干预措施
ESG Recipients
After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment.
干预措施: OverStitch™ or OverStitch NXT™ (Device)
Lifestyle Modification
After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program.
干预措施: Lifestyle Modification (Behavioral)
结局指标
主要结局
Percent total body weight loss (TBWL) at 1 year from baseline
时间窗: 12 months
The study will measure the percentage of total body weight loss for a period of one year from baseline.
次要结局
- Change in body mass index (BMI)(12 months)
- Percentage of excess weight loss(12 months)
- Percentage of patients that achieved 5%, 10% and 15% total body weight loss(12 months)
- Metabolic markers, if available(12 months)
- Visit compliance and impact to responder rate(12 months)
- Rate of procedure-related serious adverse events within 1-year post-ESG(12 months)
- Change in body mass index (BMI)(12 months)
- Percentage of excess weight loss(12 months)
- Percentage of patients that achieved 5%, 10% and 15% total body weight loss(12 months)
- Metabolic markers, if available(12 months)
- Visit compliance and impact to responder rate(12 months)
- Rate of procedure-related serious adverse events within 1-year post-ESG(12 months)