Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents

Официальное название

Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide - in Adolescents (the PRESSURE Trial)

Обзор

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 or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 months after bariatric surgery, have not lost as much weight as expected.

Вмешательства

• Препарат Injectable semaglutide or injectable tirzepatide
  Subcutaneous weekly injectable medication
• Поведенческое Standard 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.

Первичные конечные точки

• Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels [Срок оценки: Baseline, 6 months postoperatively]
• Observational phase: Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels [Срок оценки: Baseline, 6 months postoperatively]
• Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels [Срок оценки: Baseline, 6 months postoperatively]
• Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA) [Срок оценки: Baseline, 6 months postoperatively]
• Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry [Срок оценки: Baseline, 6 months postoperatively]
• Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor [Срок оценки: Baseline, 6 months postoperatively]
• Observational phase: Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram [Срок оценки: Baseline, 6 months postoperatively]
• Intervention phase: Change in BMI [Срок оценки: Baseline, 26 weeks]

Вторичные конечные точки (12)

• Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels [Срок оценки: Baseline, 3 months postoperatively]
• Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels [Срок оценки: Baseline, 3 months postoperatively]
• Change in fasting Peptide YY (PYY), measured by blood levels [Срок оценки: Baseline, 3 months postoperatively]
• Change in fasting Peptide YY (PYY), measured by blood levels [Срок оценки: Baseline, 6 months postoperatively]
• Change in stimulated Peptide YY (PYY), measured by blood levels [Срок оценки: Baseline, 3 months postoperatively]
• Change in stimulated Peptide YY (PYY), measured by blood levels [Срок оценки: Baseline, 6 months postoperatively]
• Change in fasting ghrelin, measured by blood levels [Срок оценки: Baseline, 3 months postoperatively]
• Change in fasting ghrelin, measured by blood levels [Срок оценки: Baseline, 6 months postoperatively]
• Change in stimulated ghrelin, measured by blood levels [Срок оценки: Baseline, 3 months postoperatively]
• Change in stimulated ghrelin, measured by blood levels [Срок оценки: Baseline, 6 months postoperatively]
• Change in insulin sensitivity (IS), measured by fasting blood insulin levels [Срок оценки: Baseline, 3 months postoperatively]
• Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA) [Срок оценки: Baseline, 3 months postoperatively]

Критерии участия

Observation Phase

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• 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: ≤22% BMI loss at 6-24 months postop
• If entering the Intervention phase from the existing patient pool: ≤22% BMI loss at 6-24 months postop

Критерии исключения

• Surgically correctable cause of suboptimal postoperative weight loss
• Known hypersensitivity to any component of semaglutide
• Personal or family history of medullary thyroid carcinoma
• Personal history of multiple endocrine neoplasia type 2
• Hypothalamic Obesity
• Type 2 Diabetes
• History of pancreatitis
• Uncontrolled hypertension
• Clinically significant arrhythmia or heart disease that could be exacerbated by increased heart rate
• Malignant neoplasm within the last 5 years
• Untreated thyroid disorder
• Tanner Stage 1
• Baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) ≥ 5x upper limit of normal
• Baseline Creatinine >1.2mg/dL
• Active treatment for bulimia nervosa
• Active major psychiatric disorder limiting informed consent
• Suicidal ideation of type 4 or 5 on Columbia-Suicide Severity Rating Scale (C-SSRS)
• Intentional self-harm within the previous 1 month
• Severe unmanaged depression, defined by Center for Epidemiological Studies Depression (CESD) score of 26 or greater and by clinical evaluation
• Recent change to concomitant medications for hypertension, dyslipidemia, depression or anxiety (<4 weeks prior to enrollment)
• Use of oral glucocorticoids (within 10 days of baseline visit)
• Use of metformin (within 3 months of baseline visit)
• Use of insulin secretagogues (within 4 half-lives of the medication of baseline visit)
• Current use of insulin
• Use of anti-obesity medications (within 4 half-lives of the medication of baseline visit)
• Current pregnancy
• For females of reproductive potential: Plan to become pregnant in the next 8 months
• For females of reproductive potential: Not on contraception (i.e. two forms of birth control for example oral birth control pills and condoms) for at least 1 month prior to enrollment and agreement to use these during study participation and for an additional 8 weeks after the final dose of study medication

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Childrens Hospital Colorado — Aurora

Идентификаторы

NCT: NCT06575738 · 21-3604 · 5K23HL163480-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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