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.
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)
Study Type
OBSERVATIONAL
Enrollment
150
The OverStitch™ or OverStitch NXT™ Endoscopic Suturing System was used as part of each patient's ESG procedure within the routine clinical practice.
Patients participated in a lifestyle modification program for weight loss management.
Bariendo
Miami, Florida, United States
RECRUITINGBrigham & Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGWest Virginia University
Morgantown, West Virginia, United States
NOT_YET_RECRUITINGPercent total body weight loss (TBWL) at 1 year from baseline
The study will measure the percentage of total body weight loss for a period of one year from baseline.
Time frame: 12 months
Change in body mass index (BMI)
The study will measure change in BMI for a period of one year from baseline.
Time frame: 12 months
Percentage of excess weight loss
The study will measure the percentage of excess weight loss for a period of one year from baseline.
Time frame: 12 months
Percentage of patients that achieved 5%, 10% and 15% total body weight loss
The study will measure the percentage of patients that achieved 5%, 10% and 15% total body weight loss in the one year from baseline.
Time frame: 12 months
Metabolic markers, if available
Metabolic markers include changes from baseline in the following items: 1. HbA1c 2. Fasting blood glucose 3. Total cholesterol 4. LDL 5. HDL 6. Triglycerides 7. Blood pressure (systolic and diastolic blood pressure)
Time frame: 12 months
Visit compliance and impact to responder rate
Responders are defined as \>= 10% TBWL. This analysis will analyze if responder rate improves with higher visit compliance (number of completed interactions with a provider for weight loss management).
Time frame: 12 months
Rate of procedure-related serious adverse events within 1-year post-ESG
The study will examine the rate of procedure-related serious adverse events within 1-year post-ESG.
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Time frame: 12 months