Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
NCT Number: NCT06575738
Acronym: PRESSURE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity|Adolescent Obesity|Body-Weight Trajectory|Weight Loss Trajectory|Bariatric Surgery|Anti-obesity Agents
Interventions: DRUG: Injectable semaglutide|BEHAVIORAL: Usual postoperative care
Sponsor: University of Colorado, Denver
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-10
Locations: Children's Hospital Colorado, Aurora, Colorado, 80045, United States

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.

Primary Outcome Measures: Observational 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, 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, 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, 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, Baseline, 12 months postoperatively|Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry, RMR from canopy indirect calorimetry, Baseline, 12 months postoperatively|Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor, Mean 24 hour systolic BP, 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, Baseline, 12 months postoperatively|Intervention phase: Change in BMI, \[(BMI at 26 weeks-Weight at Intervention Baseline)\]/(BMI at Intervention Baseline)\] \* 100, Baseline, 26 weeks
Secondary Outcome Measures: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels, GLP1 levels are measured prior to an oral mixed meal tolerance test, 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, 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, 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, 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, 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, Baseline, 12 months postoperatively|Change in fasting ghrelin, measured by blood levels, Ghrelin levels are measured prior to an oral mixed meal tolerance test, Baseline, 3 months postoperatively|Change in fasting ghrelin, measured by blood levels, Ghrelin levels are measured prior to an oral mixed meal tolerance test, Baseline, 12 months postoperatively|Change in stimulated ghrelin, measured by blood levels, Ghrelin levels are measured during an oral mixed meal tolerance test, Baseline, 3 months postoperatively|Change in stimulated ghrelin, measured by blood levels, Ghrelin levels are measured during an oral mixed meal tolerance test, 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, 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, Baseline, 3 months postoperatively|Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry, RMR from canopy indirect calorimetry, Baseline, 3 months postoperatively|Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor, Mean 24 hour systolic BP, 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, Baseline, 3 months postoperatively|Intervention Phase: Eligibility rate, (Patients meeting inclusion and exclusion criteria/Total patients screened)\*100, Up to 150 weeks|Intervention Phase: Enrollment rate, (Participants enrolled/Patients eligible)\*100, Up to 154 weeks|Intervention Phase: Retention rate, (Participants completing all intervention visits/Patients enrolled)\*100, Up to 184 weeks|Intervention Phase: Mean maximum tolerated semaglutide dose, Mean maximum tolerated dose (mg) of weekly injectable semaglutide, 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, 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, Up to 30 weeks