The study plans to learn more about what happens to the body after bariatric surgery in people 12 to 24 years old. The study aims to understand why people respond differently to bariatric surgery and how to define success beyond weight loss alone. The study also plans to learn more about whether a medication (semaglutide or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 months after bariatric surgery, have not lost as much weight as expected.
Signed and dated informed consent form
Willingness to comply with all study procedures and availability for the duration of the study
Male or female biological sex, age 12 through 24 years
In the preoperative pathway for vertical sleeve gastrectomy
Planned Roux-en-Y gastric bypass
Hypothalamic obesity
Type 2 Diabetes
Current use of oral glucocorticoids (i.e. within 10 days of baseline visit)
Parallel
Injectable semaglutide or injectable tirzepatide
DrugSubcutaneous weekly injectable medication
Standard postoperative care
BehavioralStandard postoperative care consists of behaviorally-focused interventions delivered by the interdisciplinary Bariatric Surgery Center team targeting nutrition, physical activity, sleep, and mental health at standard postoperative intervals.
Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured prior to an oral mixed meal tolerance test
Observational phase: Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured during an oral mixed meal tolerance test
Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels
Fasting insulin levels are measured. IS is defined as 1/fasting insulin
Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)
Percent FFM is calculated as (1-Percent Fat Mass) from DXA
Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured prior to an oral mixed meal tolerance test
Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured during an oral mixed meal tolerance test
Change in fasting Peptide YY (PYY), measured by blood levels
PYY levels are measured prior to an oral mixed meal tolerance test
Change in fasting Peptide YY (PYY), measured by blood levels
PYY levels are measured prior to an oral mixed meal tolerance test
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
