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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 24
Healthy Volunteers: f
View:

• 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

• 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: ≤20% BMI loss at 1 year postop

• If entering the Intervention phase from the existing patient pool: ≤20% BMI loss at 1-2 years postop

Locations
United States
Colorado
Childrens Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Jaime Moore, MD MPH
jaime.moore@cuanschutz.edu
303-724-8419
Time Frame
Start Date: 2024-10-11
Estimated Completion Date: 2027-10
Participants
Target number of participants: 48
Treatments
No_intervention: Observational
Participants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 12 months postoperatively.
Experimental: 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.
Active_comparator: Standard Postoperative Care
Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care.
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov