Status:
UNKNOWN
ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)
Lead Sponsor:
True You Weight Loss
Conditions:
Obesity
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The purpose of this research is to investigate the combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty on circulating plasma ghrelin, satiation, and total body weight loss, as ...
Detailed Description
Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interven...
Eligibility Criteria
Inclusion
- 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 True You Weight Loss
- Access to internet
- Reliable transportation to and from Cary, North Carolina surrounding area
Exclusion
- Younger than 21 years of age
- Older than 65 years of age
- 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 or are incompetent, unconscious or unable to express their consent for any reason
- 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.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05992103
Start Date
September 14 2023
End Date
May 15 2025
Last Update
December 7 2023
Active Locations (1)
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1
True You Weight Loss
Cary, North Carolina, United States, 27513