RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-10
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06575738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed and dated informed consent form
  2. * Willingness to comply with all study procedures and availability for the duration of the study
  3. * Male or female biological sex, age 12 through 24 years
  4. * In the preoperative pathway for vertical sleeve gastrectomy
  1. * Planned Roux-en-Y gastric bypass
  2. * Hypothalamic obesity
  3. * Type 2 Diabetes
  4. * Use of oral glucocorticoids (within 10 days of baseline visit)
  5. * Use of metformin (within 3 months of baseline visit)
  6. * Use of insulin secretagogues (within 4 half-lives of the medication of baseline visit)
  7. * Current use of insulin
  8. * Use of anti-obesity medications (within 4 half-lives of the medication of baseline visit)

Contacts and Locations

Study Contact

Jaime Moore, MD MPH
CONTACT
303-724-8419
jaime.moore@cuanschutz.edu

Principal Investigator

Jaime Moore, MD MPH
PRINCIPAL_INVESTIGATOR
University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

Childrens Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Jaime Moore, MD MPH, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-10
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-09-10
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Anti-obesity medication
  • Bariatric Surgery
  • Bariatric Surgery Post Operative Outcomes
  • Semaglutide
  • Sleeve gastrectomy

Additional Relevant MeSH Terms

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