DRUG
Injectable semaglutide or injectable tirzepatide
Subcutaneous weekly injectable medication
Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
Status
Recruiting
Phase
Phase 1
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
BEHAVIORAL
Standard postoperative care
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.
Timeline
From registration to results.
First posted
Aug 28, 2024
Study start
Oct 11, 2024
Primary completion
Sep 1, 2027
Study completion
Oct 1, 2027
Results posted
Not reported
Registry updated
Jul 15, 2026
Outcomes
What the study measures.
Primary outcomes
Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
Time frame · Baseline, 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 levels
Time frame · Baseline, 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 levels
Time frame · Baseline, 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)
Time frame · 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 calorimetry
Time frame · Baseline, 6 months postoperatively
RMR from canopy indirect calorimetry
Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor
Time frame · Baseline, 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 echocardiogram
Time frame · Baseline, 6 months postoperatively
Resting supine 2-dimensional echocardiogram
Intervention phase: Change in BMI
Time frame · Baseline, 26 weeks
\[(BMI at 26 weeks-Weight at Intervention Baseline)\]/(BMI at Intervention Baseline)\] \* 100
Secondary outcomes
Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
Time frame · Baseline, 3 months postoperatively
GLP1 levels are measured prior to an oral mixed meal tolerance test
Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels
Time frame · Baseline, 3 months postoperatively
GLP1 levels are measured during an oral mixed meal tolerance test
Change in fasting Peptide YY (PYY), measured by blood levels
Time frame · Baseline, 3 months postoperatively
PYY levels are measured prior to an oral mixed meal tolerance test
Change in fasting Peptide YY (PYY), measured by blood levels
Time frame · Baseline, 6 months postoperatively
PYY levels are measured prior to an oral mixed meal tolerance test
Change in stimulated Peptide YY (PYY), measured by blood levels
Time frame · Baseline, 3 months postoperatively
Plasma PYY levels are measured during an oral mixed meal tolerance test
Change in stimulated Peptide YY (PYY), measured by blood levels
Time frame · Baseline, 6 months postoperatively
Plasma PYY levels are measured during an oral mixed meal tolerance test
Change in fasting ghrelin, measured by blood levels
Time frame · Baseline, 3 months postoperatively
Ghrelin levels are measured prior to an oral mixed meal tolerance test
Change in fasting ghrelin, measured by blood levels
Time frame · Baseline, 6 months postoperatively
Ghrelin levels are measured prior to an oral mixed meal tolerance test
Change in stimulated ghrelin, measured by blood levels
Time frame · Baseline, 3 months postoperatively
Ghrelin levels are measured during an oral mixed meal tolerance test
Change in stimulated ghrelin, measured by blood levels
Time frame · Baseline, 6 months postoperatively
Ghrelin levels are measured during an oral mixed meal tolerance test
Eligibility
Who can take part.
- Minimum age
- 12 Years
- Maximum age
- 24 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Childrens Hospital Colorado
Aurora, Colorado, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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