True You is excited to have launched a new study developed and led by our True You Research Team, for those interested in ESG and contributing to evidence-based research.
- 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
- Those who plan to receive an endoscopic sleeve gastroplasty at True You facility regardless of the research
- 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 called gastric fundic ablation to reduce hunger when combined with ESG in a single-stage, same day procedure.
- When: From the time of study enrollment, your participation would last up to 15 months. This includes 3 months for screening assessments and 12 months for active study participation activities.
- The procedure will be carried out at the True You Weight Loss clinic in Cary (2001 Weston Parkway, Cary, NC 27513).
- Why: To investigate a new technique that may reduce hunger and may boost the weight loss seen with ESG.
- Compensation: Participants will be responsible for the cost of the ESG procedure but will be compensated for their study-related time, effort, and inconvenience with non-monetary as well as monetary means. This includes up to $1,900 in compensation and incentive payments.
Additional information about the study can be accessed via ClinicalTrials.gov.
Study status: enrollment complete; findings pending
