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Understanding Bariatric Surgery and Adjunct Semaglutide in Adolescents

This study is for young people aged 12 to 24 who are planning to have vertical sleeve gastrectomy (a type of weight-loss surgery). Researchers want to understand how your body changes after bariatric surgery and why some people respond differently. They will measure changes in certain hormones like GLP1 (glucagon-like peptide-1) and how sensitive your body is to insulin. The study also wants to see if medications like semaglutide or tirzepatide can help those who haven't lost as much weight as expected 6 to 24 months after surgery. Success in this study means understanding these body changes and how these medications might help.

Study design
This is an interventional study planning to enroll 40 participants. It is not specified if it is randomized or blinded.
What's involved
You would participate in standard postoperative care, which includes behavioral interventions focused on nutrition, physical activity, sleep, and mental health. Blood samples will be taken at baseline and 6 months postoperatively.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months postoperatively for primary endpoint measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06575738

Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents

Recruiting
PHASE1Ages 12–24InterventionalTreatment
University of Colorado, Denver
~40 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Injectable semaglutide or injectable tirzepatideStandard postoperative care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
Measured over Baseline, 6 months postoperatively
+7 more outcomes measured

Conditions

Obesity
Adolescent Obesity
Body-Weight Trajectory
Weight Loss Trajectory
Bariatric Surgery
Anti-obesity Agents

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Jaime Moore, MD MPH · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Jaime Moore, MD MPH
[email protected]
303-724-8419
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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
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 (\<4 weeks prior to enrollment)
Use of oral glucocorticoids (within 10 days of baseline visit)
Use of metformin (within 3 months of baseline visit)
Use of insulin secretagogues (within 4 half-lives of the medication of baseline visit)
Current use of insulin
Use of anti-obesity medications (within 4 half-lives of the medication of baseline visit)
Current pregnancy
For females of reproductive potential: Plan to become pregnant in the next 8 months
For females of reproductive potential: Not on contraception (i.e. two forms of birth control for example oral birth control pills and condoms) for at least 1 month prior to enrollment and agreement to use these during study participation and for an additional 8 weeks after the final dose of study medication

What this trial measures

  • Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levelsBaseline, 6 months postoperatively

    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 levelsBaseline, 6 months postoperatively

    GLP1 levels are measured during an oral mixed meal tolerance test

  • Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levelsBaseline, 6 months postoperatively

    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)Baseline, 6 months postoperatively

    Percent FFM is calculated as (1-Percent Fat Mass) from DXA

  • Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetryBaseline, 6 months postoperatively

    RMR from canopy indirect calorimetry

  • Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitorBaseline, 6 months postoperatively

    Mean 24 hour systolic BP

  • Observational phase: Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogramBaseline, 6 months postoperatively

    Resting supine 2-dimensional echocardiogram

  • Intervention phase: Change in BMIBaseline, 26 weeks

    \[(BMI at 26 weeks-Weight at Intervention Baseline)\]/(BMI at Intervention Baseline)\] \* 100