Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide - in Adolescents (the PRESSURE Trial)
Overview
- Phase
- Phase 1
- Intervention
- Injectable semaglutide
- Conditions
- Obesity
- Sponsor
- University of Colorado, Denver
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Active Medication + Standard Postoperative Care
Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care plus weekly subcutaneous injectable semaglutide for 26 weeks. Initial dose is 0.25mg and is escalated every 4 weeks as tolerated (0.5mg, 1.0mg, 1.7mg, 2.4mg) for a total exposure of 26 weeks.
Intervention: Injectable semaglutide
Active Medication + Standard Postoperative Care
Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care plus weekly subcutaneous injectable semaglutide for 26 weeks. Initial dose is 0.25mg and is escalated every 4 weeks as tolerated (0.5mg, 1.0mg, 1.7mg, 2.4mg) for a total exposure of 26 weeks.
Intervention: Standard postoperative care
Standard Postoperative Care
Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care.
Intervention: Standard postoperative care
Observational
Participants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 12 months postoperatively.
Outcomes
Primary Outcomes
Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels
Time Frame: 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
Time Frame: Baseline, 12 months postoperatively
GLP1 levels are measured during an oral mixed meal tolerance test
Observational phase: Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram
Time Frame: Baseline, 12 months postoperatively
Resting supine 2-dimensional echocardiogram
Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels
Time Frame: 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)
Time Frame: Baseline, 12 months postoperatively
Percent FFM is calculated as (1-Percent Fat Mass) from DXA
Intervention phase: Change in BMI
Time Frame: Baseline, 26 weeks
\[(BMI at 26 weeks-Weight at Intervention Baseline)\]/(BMI at Intervention Baseline)\] \* 100
Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry
Time Frame: Baseline, 12 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, 12 months postoperatively
Mean 24 hour systolic BP
Secondary Outcomes
- Change in fasting Peptide YY (PYY), measured by blood levels(Baseline, 12 months postoperatively)
- Change in stimulated Peptide YY (PYY), measured by blood levels(Baseline, 12 months postoperatively)
- Intervention Phase: Eligibility rate(Up to 150 weeks)
- Intervention Phase: Mean maximum tolerated semaglutide dose(Baseline, 26 weeks)
- Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels(Baseline, 3 months postoperatively)
- Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels(Baseline, 3 months postoperatively)
- Change in fasting ghrelin, measured by blood levels(Baseline, 12 months postoperatively)
- Change in stimulated ghrelin, measured by blood levels(Baseline, 12 months postoperatively)
- Change in insulin sensitivity (IS), measured by fasting blood insulin levels(Baseline, 3 months postoperatively)
- Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor(Baseline, 3 months postoperatively)
- Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)(Baseline, 3 months postoperatively)
- Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry(Baseline, 3 months postoperatively)
- Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram(Baseline, 3 months postoperatively)
- Intervention Phase: Enrollment rate(Up to 154 weeks)
- Intervention Phase: Retention rate(Up to 184 weeks)
- 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)
- 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)
- Change in fasting Peptide YY (PYY), measured by blood levels(Baseline, 3 months postoperatively)
- Change in stimulated Peptide YY (PYY), measured by blood levels(Baseline, 3 months postoperatively)
- Change in fasting ghrelin, measured by blood levels(Baseline, 3 months postoperatively)
- Change in stimulated ghrelin, measured by blood levels(Baseline, 3 months postoperatively)