Weight Loss
Conditions
Brief summary
The purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. The current standard of care is a procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this method to a Gastric Emptying Breath Test (GEBT).
Interventions
OTHERNSSM and GEBT
The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.
Sponsors
Mayo Clinic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be 22-65 years of age at time of enrollment * Subjects must already be consented to 17-007934 or 19-001254 * Subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing. * If female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum HCG at screening/baseline * Must be willing and able to travel, as needed, to the Investigator's office to complete all routine follow-up visits
Exclusion criteria
* Persons presently or soon to be incarcerated * Females who are pregnant or suspect they may be pregnant * Persons with nicotine and/or alcohol dependence * Patients with cognitive impairment that limits their ability to make autonomous decisions * Known allergies or sensitivities to study materials (eggs and spirulina) * Assessed, by the physician or delegate, that enrollment would not be appropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of T1/2 | Baseline, 2 months, 6 months | The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an EGRWL procedure. |
Countries
United States
Outcome results
None listed