Obesity, Adolescent Obesity, Body-Weight Trajectory, Weight Loss Trajectory, Bariatric Surgery, Anti-obesity Agents
Conditions
Keywords
Obesity, Anti-obesity medication, Bariatric Surgery, Bariatric Surgery Post Operative Outcomes, Semaglutide, Sleeve gastrectomy
Brief 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) can help people 12 to 24 years old who, between 1 and 2 years after bariatric surgery, have not lost as much weight as expected.
Interventions
DRUGInjectable semaglutide
Subcutaneous weekly injectable semaglutide
BEHAVIORALStandard 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
Inclusion 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: ≤20% BMI loss at 1 year postop * If entering the Intervention phase from the existing patient pool: ≤20% BMI loss at 1-2 years postop
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels | Baseline, 12 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 | Baseline, 12 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 | Baseline, 12 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, 12 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 | Baseline, 12 months postoperatively | RMR from canopy indirect calorimetry |
| Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor | Baseline, 12 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 | Baseline, 12 months postoperatively | Resting supine 2-dimensional echocardiogram |
| Intervention phase: Change in BMI | Baseline, 26 weeks | \[(BMI at 26 weeks-Weight at Intervention Baseline)\]/(BMI at Intervention Baseline)\] \* 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry | Baseline, 3 months postoperatively | RMR from canopy indirect calorimetry |
| Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor | Baseline, 3 months postoperatively | Mean 24 hour systolic BP |
| Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram | Baseline, 3 months postoperatively | Resting supine 2-dimensional echocardiogram |
| Intervention Phase: Eligibility rate | Up to 150 weeks | (Patients meeting inclusion and exclusion criteria/Total patients screened)\*100 |
| Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels | Baseline, 3 months postoperatively | GLP1 levels are measured prior to an oral mixed meal tolerance test |
| Intervention Phase: Retention rate | Up to 184 weeks | (Participants completing all intervention visits/Patients enrolled)\*100 |
| Intervention Phase: Mean maximum tolerated semaglutide dose | Baseline, 26 weeks | Mean maximum tolerated dose (mg) of weekly injectable semaglutide |
| Intervention Phase: Number of participants with at least one serious adverse event (AE) in the active medication group, measured by a count | Up to 30 weeks | Individual participants with serious AEs will be counted |
| Intervention Phase: Number of participants with an adverse event (AE) that leads to discontinuation of the medication, measured by a count | Up to 30 weeks | Participants experiencing an AE that leads to medication discontinuation will be counted |
| Intervention Phase: Enrollment rate | Up to 154 weeks | (Participants enrolled/Patients eligible)\*100 |
| Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels | 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 | Baseline, 3 months postoperatively | PYY levels are measured prior to an oral mixed meal tolerance test |
| Change in stimulated Peptide YY (PYY), measured by blood levels | Baseline, 3 months postoperatively | Plasma PYY levels are measured during an oral mixed meal tolerance test |
| Change in fasting ghrelin, measured by blood levels | Baseline, 3 months postoperatively | Ghrelin levels are measured prior to an oral mixed meal tolerance test |
| Change in stimulated ghrelin, measured by blood levels | Baseline, 3 months postoperatively | Ghrelin levels are measured during an oral mixed meal tolerance test |
| Change in insulin sensitivity (IS), measured by fasting blood insulin levels | Baseline, 3 months postoperatively | Fasting insulin levels are measured. IS is defined as 1/fasting insulin |
| Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA) | Baseline, 3 months postoperatively | Percent FFM is calculated as (1-Percent Fat Mass) from DXA |
Countries
United States
Contacts
Primary ContactJaime Moore, MD MPH
Outcome results
None listed