Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolesc
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 (semagluti
| Condition(s) | Obesity, Adolescent Obesity, Body-Weight Trajectory, Weight Loss Trajectory, Bariatric Surgery, Anti-obesity Agents |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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) can help people 12 to 24 years old who, between 1 and 2 years after bariatric surgery, have not lost as much weight as expected. |
| Who can participate | Observation Phase Inclusion Criteria: * 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 Exclusion Criteria: * Planned Roux-en-Y gastric bypass * Hypothalamic obesity * Type 2 Diabetes * Current use of oral glucocorticoids (i.e. within 10 days of baseline visit) * Current use of insulin Intervention/Treatment Phase Inclusion Criteria: * Signed and dated informed consent form * Status post vertical sleeve gastrectomy * Male or female biological sex, age 12 through 24 years * Meeting minimum nutrition goals * Obesity: age 12-17 years: BMI ≥95th%ile for age/sex \| age 18-24 years: BMI ≥ 30k |
| Ages | 12 Years to 24 Years |
| Sex | All |
| Lead sponsor | University of Colorado, Denver |
| Locations | Aurora, Colorado, United States |
| Start date | 2024-10-11 |
| NCT ID | NCT06575738 |
| Official listing | https://clinicaltrials.gov/study/NCT06575738 |