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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL163480-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | No Intervention | Participants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 12 months postoperatively. | |
| Active Medication + Standard Postoperative Care | Experimental | 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. |
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| Standard Postoperative Care | Active Comparator | Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable semaglutide | Drug | Subcutaneous weekly injectable semaglutide |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Observation Phase
Inclusion Criteria:
Exclusion Criteria:
Intervention/Treatment Phase
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime Moore, MD MPH | Contact | 303-724-8419 | jaime.moore@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jaime Moore, MD MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Standard postoperative care | Behavioral | 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. |
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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 |
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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| D000077962 | Body-Weight Trajectory |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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