Understanding the effects of bariatric surgery and semaglutide in adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the physiological responses of adolescents aged 12 to 24 years following bariatric surgery, specifically vertical sleeve gastrectomy. It aims to explore the variability in weight loss outcomes and define success beyond just weight reduction. Additionally, the study evaluates the effectiveness of semaglutide, an anti-obesity medication, in adolescents who have not achieved expected weight loss 1 to 2 years post-surgery. Participants will receive standard postoperative care along with the medication if eligible.

Why it matters

Who can join: the full rules

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 (\<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

Where it's running

• Childrens Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Jaime Moore, MD MPH — University of Colorado, Denver
• Study coordinator: Jaime Moore, MD MPH
• Email: jaime.moore@cuanschutz.edu
• Phone: 303-724-8419

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.