Innovation in Research

True You is committed to providing safe, effective, non-surgical, outpatient weight loss procedures that deliver surgical-level outcomes. We are also proud to share our dedication to improving endoscopic bariatric therapies and advancing patient-related outcomes through focused, innovative, and groundbreaking research. True You is proud to collaborate and lead innovative research projects to advance the field and ensure patient-centered care while investigating new endoscopic methods and technologies.

Active Research Projects

Lean Body Mass after ESG: Factors & Changes

True You is conducting a research study is to evaluate the change in lean body mass (LBM) and body composition in patients that have an ESG procedure.

Status and Outcomes

Ablate Weight II Study

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. 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.

Status and Outcomes

Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy

This clinical trial aims to investigate whether this experimental treatment involving the ablation of up to 70% of the gastric mucosa would result in weight loss.

Status and Outcomes

HAPCET 2.0 Study

True You is excited to launch the new Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET 2.0): A Single-Center Randomized Controlled Validation Trial in a Community Setting. This investigational research study will be led by our True You Research Team. Are you interested in ESG and contributing to evidence-based research?

Status and Outcomes

ESG Response after IGB: Clinical Outcomes

Patient concerns about the invasiveness of weight loss has led to considerable interest in the minimally invasive field of endoscopic bariatric therapies. These include space-occupying intragastric balloons (IGBs) and the endoscopic sleeve gastroplasty (ESG). These stomach-targeting therapies affect appetite through non-hormonal, gastric sensorimotor influences on appetite by improving satiation and satiety.

Status and Outcomes

TORe + Aftercare: Big Weight Loss

Roux en Y gastric bypass (RYGB) is one of the most effective weight loss therapies, but due to the chronic progressive nature of obesity, nearly one third of patients will experience weight regain. As the highest-volume, non-academic TORe center in the United States, True You Weight Loss has a unique opportunity to evaluate the weight loss and safety outcomes of this procedure in the community setting.

Status and Outcomes

Ablate Weight Study

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.

Status and Outcomes

Class III Obesity & ESG: Weight, Health Benefits

The aim of this project was to determine if ESG is a safe and effective option for patients with a BMI of 40+ who are not interested in, or eligible for, traditional bariatric therapy through a retrospective, international, multicenter chart review. This retrospective study evaluated the data of over 400 patients who underwent ESG by one of two experienced bariatric endoscopists (Dr. Christopher McGowan of True You Weight Loss and Dr. Anna Hoff of Angioskope in Sao Paulo, Brazil) between May of 2018 and March of 2022 with class III obesity (BMI 40+).

Status and Outcomes

PERCEBT: Unveiling Endoscopy Patient Profiles

Endoscopic bariatric therapies (EBTs), including the endoscopic sleeve gastroplasty (ESG) and intragastric balloons (IGBs), represent lower-risk yet effective weight loss options for patients not interested in, or eligible for, traditional bariatric surgery. However, there is limited scientific literature addressing the factors associated with receptivity to EBTs in eligible patients.

Status and Outcomes

Spatz3 Adjustable Balloon Post Approval Study

The Spatz3 Adjustable Balloon System is the world’s first and only adjustable gastric balloon. The Spatz Balloon was approved by the FDA in October 2021, after demonstrating an 84% success rate and 15% average total body weight loss, results that far exceeded every non-adjustable balloon in non-comparative studies.

Status and Outcomes

Research Team

dr. christopher mcgowan
Dr. Christopher McGowan, MD, MSCR, AGAF: Research Director

Dr. McGowan directs the Clinical Research team at True You Weight Loss, bringing nearly 20 years of clinical research expertise and the same passion and energy that he dedicates to his patients’ weight loss outcomes. Dr. McGowan completed a GI Epidemiology fellowship at the University of North Carolina at Chapel Hill, where he earned a Master of Science in Clinical Research from the prestigious Gillings School of Global Public Health. He has authored numerous first-author publications in the leading scientific journals, including: Gastroenterology; Gastrointestinal Endoscopy; Obesity Surgery; Clinical Gastroenterology and Hepatology; Hepatology; Radiology; Endoscopy. Dr. McGowan is excited to contribute to advancing the field of endoscopic weight loss through True You Weight Loss’ innovative research efforts.

dr. daniel b. maselli endobariatric physician
Dr. Daniel B. Maselli, MD: Associate Research Director

Dr. Maselli has passion for endoscopic bariatric therapies (EBTs), which includes conducting research to answer pertinent questions about how we can understand, modify, and improve these therapies to achieve better outcomes for our patients. His primary interests for research are the use of EBTs for fatty liver disease and other obesity-associated comorbidities, understanding the physiologic mechanisms of EBTs, defining a patient-tailored approach to EBT options, combination EBT and anti-obesity medications, and the development of novel EBTs. Dr. Maselli's interest in clinical research began while he was a gastroenterology fellow at the Mayo Clinic where he was mentored in the research of EBT, anti-obesity medications, and gastrointestinal motor function. Dr. Maselli also completed Mayo Clinic’s postdoctoral certificate program in clinical research at the Center for Clinical and Translational Science. Dr. Maselli has published widely in both medical textbooks and medical journals and looks forward to continuing to drive the field of EBT forward with novel and cutting-edge research at True You Weight Loss.

dr. lauren l. donnangelo, md, abom endobariatric physician
Dr. Lauren Donnangelo, MD, ABOM: Physician-Investigator

Dr. Donnangelo is passionate about research and innovation in the fields of bariatric endoscopy, obesity, gastroenterology, and medical education. She has received national and institutional research grants through the American Gastroenterological Association Academy of Educators, Duke, the Howard Hughes Medical Institute Science for Life Program, and the Lawrence M. Goodman Research Trust. Dr. Donnangelo was named an Emerging Liver Scholar by the American Association for the Study of Liver Diseases Foundation in 2019, and her work has been featured in leading scientific journals including Gastroenterology, Clinical Gastroenterology and Hepatology, Gastrointestinal Endoscopy, and Obesity Surgery. Dr. Donnangelo is excited to continue to advance the field of endobariatrics through state-of-the-art research, innovation, and education.

shannon casey clinical research project manager
Shannon Casey, Clinical Research Project Manager

Shannon graduated from the University of South Florida with dual degrees in gerontology and biomedical sciences and a minor in public health. She continued her studies at the University of North Carolina at Greensboro, where she graduated with a masters in gerontology. While her research interest was first piqued in the laboratory helping with benchtop research, she found the most joy interacting with patients in the clinical research setting. She has worked in research study and site management for various disciplines, including gastroenterology, dermatology, neurology, and gynecology. She is excited to have found her home at True You Weight Loss, working alongside staff and providers who are advancing patient-centered care and weight loss research.

chase wooley clinical research coordinator
Chase Wooley, Clinical Research Coordinator

Chase earned a Bachelor of Science in Biology at the University of North Carolina at Chapel Hill. As an undergraduate, he fell in love with clinical research while studying prenatal substance abuse and how it relates to baby brain development. He has served as a physical activity coach and health educator while assisting in studies aimed at improving care and outcomes for individuals with osteoarthritis. He has also worked as an EMT, assisted with COVID-19 outreach, and volunteered in projects to raise awareness about health disparities for underserved and low-income populations. Chase is excited to continue pursuing research that is truly impactful and will improve the well-being of patients.

Research Training

As a team, True You is committed to conducting ethical, responsible, and patient-centered research in a professional and comfortable setting. That is why our medical professionals including our MDs, RDs, and NPs are certified and have successfully completed training from The Association of Clinical Research Professionals for human research protection.

Frequently Asked Questions

Why should I participate in research?

Clinical research is the primary source of medical and healthcare advancement. By participating in research, patients can actively engage in their own health while helping others. As a voluntary research participant, you are contributing to medical research to help discover better ways to prevent, diagnose, and treat disease.

What is an IRB and why does it matter?

All research involving human subjects requires an Institutional Review Board (IRB). An IRB is an independent body consisting of medical, scientific, and non-scientific members. The purpose of an IRB is to ensure the safety, welfare and the rights of participants are protected. True You conducts research with the IRB oversight of WCG IRB ( whose responsibilities include the protection of our patients participating in a clinical trial in addition to the ethical and scientific review of the clinical trial protocol and other study-related documents and procedures. True You is dedicated to protecting our patients while ensuring scientific integrity and complying with local regulations and good clinical practice.

Will my participation in research be kept private?

Yes. Researchers are required by law to keep all information confidential. The primary way by which this is done is to assign a study ID to all study participants so that names or other identifying information is removed for your protection and privacy. Further, access to your private information and your medical record will be maintained in a secure, encrypted, password- protected electronic health record.

What is informed consent?

The informed consent process is an essential part of the protection of research participants. Informed consent is an ongoing conversation and process to help patients decide whether or not to participate in a clinical trial, by understanding their role as a “subject of research”. The informed consent includes an explanation of the research purpose, how the research is conducted, the potential risks and benefits of participating, and the voluntary nature of participation. Documentation of informed consent is obtained by using an WCG IRB approved form that will be signed by the participant and the investigator.

Our informed consent process will include the following:

  • A statement explaining that the study involves research.
  • An explanation of the purposes of the research.
  • The expected length of time for participation.
  • A description of all the procedures that will be completed during enrollment on the clinical trial.
  • Information about all experimental procedures that will be completed during the clinical trial.
  • A description of any reasonably foreseeable risks or discomforts.
  • A description of any benefits to you or to others which may reasonably be expected from the research.
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to you.
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
  • For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the participant.
  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Source: FDA Gov | Informed Consent

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