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Recruiting
NCT06575738
Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
Conditions: Obesity, Adolescent Obesity, Body-Weight Trajectory, Weight Loss Trajectory, Bariatric Surgery, Anti-obesity Agents
Sex: All
Ages: 12 Years – 24 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 40
Sponsor: University of Colorado, Denver
Location: Childrens Hospital Colorado Aurora Colorado
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 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.
Eligibility Criteria
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 ≥ 30kg/m\^2
* If entering the Intervention phase from the Observational phase: ≤22% BMI loss at 6-24 months postop
* If entering the Intervention phase from the existing patient pool: ≤22% BMI loss at 6-24 months postop
Exclusion Criteria:
* Surgically correctable cause of suboptimal postoperative weight loss
* Known hypersensitivity to any component of semaglutide
* Personal or family history of medullary thyroid carcinoma
* Personal history of multiple endocrine neoplasia type 2
* Hypothalamic Obesity
* Type 2 Diabetes
* History of pancreatitis
* Uncontrolled hypertension
* Clinically significant arrhythmia or heart disease that could be exacerbated by increased heart rate
* Malignant neoplasm within the last 5 years
* Untreated thyroid disorder
* Tanner Stage 1
* Baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) ≥ 5x upper limit of normal
* Baseline Creatinine \>1.2mg/dL
* Active treatment for bulimia nervosa
* Active major psychiatric disorder limiting informed consent
* Suicidal ideation of type 4 or 5 on Columbia-Suicide Severity Rating Scale (C-SSRS)
* Intentional self-harm within the previous 1 month
* Severe unmanaged depression, defined by Center for Epidemiological Studies Depression (CESD) score of 26 or greater and by clinical evaluation
* Recent change to concomitant medications for hypertension, dyslipidemia, depression or anxiety (\
Source: ClinicalTrials.gov (NCT06575738). StuddyBuddy aggregates publicly available trial information.