Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT06575738

Recruiting nowPhase 1Interventional

What this study 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 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 24 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Adolescent Obesity, Body-Weight Trajectory, Weight Loss Trajectory, Bariatric Surgery, Anti-obesity Agents

Full registry 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 (\<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

Treatments and study arms

Injectable semaglutide or injectable tirzepatide

Drug

Subcutaneous weekly injectable medication

Standard postoperative care

Behavioral

Standard postoperative care consists of behaviorally-focused interventions delivered by the interdisciplinary Bariatric Surgery Center team targeting nutrition, physical activity, sleep, and mental health at standard postoperative intervals.

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Childrens Hospital Colorado🇺🇸 Aurora, Colorado, United States
Jaime Moore, MD MPHContact