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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Subcutaneous weekly injectable semaglutide
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.
Childrens Hospital Colorado
Aurora, Colorado, United States
RECRUITINGObservational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured prior to an oral mixed meal tolerance test
Time frame: Baseline, 12 months postoperatively
Observational phase: Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured during an oral mixed meal tolerance test
Time frame: Baseline, 12 months postoperatively
Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels
Fasting insulin levels are measured. IS is defined as 1/fasting insulin
Time frame: Baseline, 12 months postoperatively
Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)
Percent FFM is calculated as (1-Percent Fat Mass) from DXA
Time frame: Baseline, 12 months postoperatively
Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry
RMR from canopy indirect calorimetry
Time frame: Baseline, 12 months postoperatively
Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor
Mean 24 hour systolic BP
Time frame: Baseline, 12 months postoperatively
Observational phase: Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram
Resting supine 2-dimensional echocardiogram
Time frame: Baseline, 12 months postoperatively
Intervention phase: Change in BMI
\[(BMI at 26 weeks-Weight at Intervention Baseline)\]/(BMI at Intervention Baseline)\] \* 100
Time frame: Baseline, 26 weeks
Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured prior to an oral mixed meal tolerance test
Time frame: Baseline, 3 months postoperatively
Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels
GLP1 levels are measured during an oral mixed meal tolerance test
Time frame: Baseline, 3 months postoperatively
Change in fasting Peptide YY (PYY), measured by blood levels
PYY levels are measured prior to an oral mixed meal tolerance test
Time frame: Baseline, 3 months postoperatively
Change in fasting Peptide YY (PYY), measured by blood levels
PYY levels are measured prior to an oral mixed meal tolerance test
Time frame: Baseline, 12 months postoperatively
Change in stimulated Peptide YY (PYY), measured by blood levels
Plasma PYY levels are measured during an oral mixed meal tolerance test
Time frame: Baseline, 3 months postoperatively
Change in stimulated Peptide YY (PYY), measured by blood levels
Plasma PYY levels are measured during an oral mixed meal tolerance test
Time frame: Baseline, 12 months postoperatively
Change in fasting ghrelin, measured by blood levels
Ghrelin levels are measured prior to an oral mixed meal tolerance test
Time frame: Baseline, 3 months postoperatively
Change in fasting ghrelin, measured by blood levels
Ghrelin levels are measured prior to an oral mixed meal tolerance test
Time frame: Baseline, 12 months postoperatively
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Change in stimulated ghrelin, measured by blood levels
Ghrelin levels are measured during an oral mixed meal tolerance test
Time frame: Baseline, 3 months postoperatively
Change in stimulated ghrelin, measured by blood levels
Ghrelin levels are measured during an oral mixed meal tolerance test
Time frame: Baseline, 12 months postoperatively
Change in insulin sensitivity (IS), measured by fasting blood insulin levels
Fasting insulin levels are measured. IS is defined as 1/fasting insulin
Time frame: Baseline, 3 months postoperatively
Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)
Percent FFM is calculated as (1-Percent Fat Mass) from DXA
Time frame: Baseline, 3 months postoperatively
Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry
RMR from canopy indirect calorimetry
Time frame: Baseline, 3 months postoperatively
Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor
Mean 24 hour systolic BP
Time frame: Baseline, 3 months postoperatively
Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram
Resting supine 2-dimensional echocardiogram
Time frame: Baseline, 3 months postoperatively
Intervention Phase: Eligibility rate
(Patients meeting inclusion and exclusion criteria/Total patients screened)\*100
Time frame: Up to 150 weeks
Intervention Phase: Enrollment rate
(Participants enrolled/Patients eligible)\*100
Time frame: Up to 154 weeks
Intervention Phase: Retention rate
(Participants completing all intervention visits/Patients enrolled)\*100
Time frame: Up to 184 weeks
Intervention Phase: Mean maximum tolerated semaglutide dose
Mean maximum tolerated dose (mg) of weekly injectable semaglutide
Time frame: Baseline, 26 weeks
Intervention Phase: Number of participants with at least one serious adverse event (AE) in the active medication group, measured by a count
Individual participants with serious AEs will be counted
Time frame: Up to 30 weeks
Intervention Phase: Number of participants with an adverse event (AE) that leads to discontinuation of the medication, measured by a count
Participants experiencing an AE that leads to medication discontinuation will be counted
Time frame: Up to 30 weeks