Status:
RECRUITING
Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Adolescent Obesity
Eligibility:
All Genders
12-24 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Observation Phase
- 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
- 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 ≥ 30kg/m\^2
- If entering the Intervention phase from the Observational phase: ≤20% BMI loss at 1 year postop
- If entering the Intervention phase from the existing patient pool: ≤20% BMI loss at 1-2 years postop
Key Trial Info
Start Date :
October 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06575738
Start Date
October 11 2024
End Date
October 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045