Actively Recruiting
Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
Led by University of Colorado, Denver · Updated on 2026-01-12
40
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Status post vertical sleeve gastrectomy
- Meeting minimum nutrition goals
- Obesity: age 12-17 years: BMI 695th percentile for age/sex; age 18-24 years: BMI 630 kg/m�b2
- If entering the Intervention phase from the Observational phase: 40% BMI loss at 1 year postop
- If entering the Intervention phase from the existing patient pool: 40% BMI loss at 1-2 years postop
You will not qualify if you...
- Planned Roux-en-Y gastric bypass
- Hypothalamic obesity
- Type 2 Diabetes
- Current use of oral glucocorticoids (within 10 days of baseline visit)
- Current use of insulin
- 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
- History of pancreatitis
- Uncontrolled hypertension
- Clinically significant arrhythmia or heart disease that could be worsened 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) 65 times upper limit of normal
- Baseline Creatinine 71.2 mg/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 (CESD score 626 and clinical evaluation)
- Recent change to medications for hypertension, dyslipidemia, depression, or anxiety (within 4 weeks prior to enrollment)
- Use of metformin (within 3 months of baseline visit)
- Use of insulin secretagogues (within 4 half-lives of medication at baseline visit)
- Use of anti-obesity medications (within 4 half-lives of medication at baseline visit)
- Current pregnancy
- For females of reproductive potential: Plan to become pregnant in next 8 months
- For females of reproductive potential: Not on contraception (two forms) for at least 1 month prior to enrollment and agreement to use during study and 8 weeks after final dose of study medication
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jaime Moore, MD MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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