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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06575738
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Injectable semaglutide — DRUG
    Subcutaneous weekly injectable semaglutide
  • 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.

Study Details

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.

Key Dates

Start date
Oct 11, 2024
Status verified
Jan 2026
Primary completion
Sep 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels [ Time Frame: Baseline, 12 months postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Childrens Hospital ColoradoAuroraColorado80045
Jaime Moore, MD MPH
[email protected]
303-724-8419

Find similar trials in Aurora, CO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Childrens Hospital Colorado· Aurora, CO

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