What is this clinical trial about?
The purpose of this research study is to evaluate the change in lean body mass (LBM) and body composition in patients that have an ESG procedure.
How to be considered for this clinical trial?
Key criteria to have:
- Be age 21 years or older
- Have a BMI ≥ 30 and ≤50 kg/m²
- Weigh less than 350 lbs
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing DXA tests, and completing diet counseling.
- Residing within a reasonable driving distance from the investigator’s offices (Cary, NC and Atlanta, GA) and able to travel to the investigator to complete all routine follow-up visits and studies as applicable
- Reliable access to wi-fi and/or internet services.
- Be planning to receive an endoscopic sleeve gastroplasty at True You facility regardless of the research
Key criteria not to have:
- You should not be taking the following drugs:
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- Weight loss medications (e.g. Meridia, Xenical, Saxenda, Januvia, Duromine or over the counter-weight loss medications)
- You should not have the following conditions:
- Be pregnant or breast-feeding or intending to get pregnant during the study
How long would trial participation last?
From the time of study enrollment, your participation would last up to 12 months.
Where is this clinical trial being held?
The procedure will be carried out at True You Weight Loss Cary (2001 Weston Parkway, Cary, NC 27513) and True You Weight Loss Atlanta (5673 Peachtree Dunwoody Rd STE 470, Atlanta, GA 30342).
What to do if I’m interested?
Contact us today if you are interested in participating. You may reach us at (919) 689-5189 and research@trueyouweightloss.com.
Will I be compensated?
Participants will be compensated for their time, effort, and inconvenience. This includes up to $420 in compensation and incentive payments
