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

Registration

Registration

NCT06575738

Acronym

PRESSURE

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

SINGLE

Status

RECRUITING

Enrollment

40

Start

2024-10-11

Primary completion

2027-09-01

Lead sponsor

University of Colorado, Denver

Conditions

Obesity; Adolescent Obesity; Body-Weight Trajectory; Weight Loss Trajectory; Bariatric Surgery; Anti-obesity Agents

Interventions

DRUG:Injectable semaglutide or injectable tirzepatide; BEHAVIORAL:Standard postoperative care

Results posted

FALSE

Secondary identifiers

NIH:5K23HL163480-02

Registered primary outcomes

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