True You is excited to have launched a new Gastric Fundus Ablation plus Endoscopic Sleeve Gastroplasty for Weight Loss (ABLATE WEIGHT) study developed and led by our True You Research Team, for those interested in ESG and contributing to evidence-based research. This study aims to evaluate a new technique to reduce hunger when combined with ESG.
- Who: Patients seeking an ESG procedure with True You.
- Key Inclusion Criteria:
- Subjects aged 21-65
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²
- History of at least one unsuccessful dietary effort to lose body weight
- Willing and able to participate in the study procedures
- Understand and voluntarily sign the informed consent
- Approved ESG candidate at TYWL
- Access to internet
- Reliable transportation
- Key Exclusion Criteria:
- Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
- Milk and/or soy allergies
- History of any stomach manipulation (including repair of hiatal hernia)
- History of disordered eating
- Patients who do not give their consent to the enrollment in the study
- Hemoglobin A1c > 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis
- Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine
- Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents
- Patients who are pregnant or who plan to become pregnant during study duration
- Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration
- Patients on chronic anticoagulation
- History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function.
- Concurrent use of weight loss medications.
- What: This study aims to evaluate a new technique to reduce hunger when combined with ESG.
- When: From the time of study enrollment, your participation would last up to 21 months. This includes 3 months for screening assessments and 18 months for active study participation activities.
- Where: We are actively recruiting patients now. Patients must reside in or near Wake County, NC to have their ESG procedure and to attend local monthly lab draws in Raleigh/Cary, NC.
- Why: To investigate a new technique that may reduce hunger and may boost the weight loss seen with ESG.
- Compensation: Patients will be compensated for their time, effort and inconvenience with non-monetary as well as monetary means. This includes up to $6,000 in compensation and incentive payments over the course of 21 months.
Additional information about the study can be accessed via ClinicalTrials.gov.
Study status: enrollment complete; findings pending
