The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone gastric fundus mucosal ablation at True You Weight Loss.
Obesity is a chronic, progressive, multifactorial disease that contributes to increasing morbidity, mortality, and economic costs worldwide. The oxyntic mucosa of the gastric fundus is the principal site for the production of the orexigenic peptide hormone ghrelin. Ghrelin activates hunger-promoting pathways of the hypothalamus and opposes the satiety-promoting actions of other gastrointestinal peptides, leading to calorie-ingesting behaviors and weight gain. A method to reduce ghrelin production and decrease fundal compliance and capacity through mucosal devitalization may confer benefit to patients seeking treatment for obesity. This is a multi-site, prospective registry of patients who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site in Cary, NC or Atlanta, GA. Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo GFMA at a True You Weight Loss site (Cary, NC or Atlanta, GA) prior to their involvement in the study. Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator. Study participants will receive follow-up care according to standard of care practices, regardless of their involvement in the research study. Standard of care nutritional practice includes a comprehensive lifestyle program with long-term nutritional support and monitoring. Patient weights and adverse events will be collected at each visit. Adverse events will be communicated to medical team members in between dedicated visits. We aim to establish a multi-site, prospective registry to longitudinally describe GMFA in adults with obesity, including patient characteristics, weight loss, improvement in weight-related medical conditions, and adverse events.
Study Type
OBSERVATIONAL
Enrollment
200
True You Weight Loss
Cary, North Carolina, United States
RECRUITINGPercent Change in Total Body Weight Loss (TBWL) from Baseline
Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.
Time frame: 12 Months
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.
Time frame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Percent Excess Weight Loss from Baseline (EWL)
Measured excess weight loss percentage from baseline following Gastric Fundic Mucosal Ablation. %EWL = (pre-op weight - post op body weight) / (pre-op weight - ideal body weight) \* 100 Ideal Body Weight (IBW): Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet
Time frame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Change in Body Mass Index (BMI) from Baseline
Measured Body Mass Index (BMI) from baseline following Gastric Fundic Mucosal Ablation. Body Mass Index (BMI) = (Weight in kilograms) / ((Height in meters)\^2)
Time frame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
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