RecruitingPhase 1

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

United States40 participantsStarted 2024-10-11

Plain-language 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.

Who can participate

Age range

12 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor

Timeframe: Baseline, 6 months postoperatively

Trial details

NCT IDNCT06575738

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

Contact for this trial

Jaime Moore, MD MPH

303-724-8419 jaime.moore@cuanschutz.edu

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

12 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry

Timeframe: Baseline, 6 months postoperatively

Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor

Timeframe: Baseline, 6 months postoperatively