NCT06575738

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
17mo left

Started Oct 2024

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Oct 2024Oct 2027

First Submitted

Initial submission to the registry

August 16, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 11, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

August 16, 2024

Last Update Submit

January 8, 2026

Conditions

ObesityAdolescent ObesityBody-Weight TrajectoryWeight Loss TrajectoryBariatric SurgeryAnti-obesity Agents

Keywords

ObesityAnti-obesity medicationBariatric SurgeryBariatric Surgery Post Operative OutcomesSemaglutideSleeve gastrectomy

Outcome Measures

Primary Outcomes (8)

  • Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels

    GLP1 levels are measured prior to an oral mixed meal tolerance test

    Baseline, 12 months postoperatively

  • Observational phase: Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels

    GLP1 levels are measured during an oral mixed meal tolerance test

    Baseline, 12 months postoperatively

  • Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels

    Fasting insulin levels are measured. IS is defined as 1/fasting insulin

    Baseline, 12 months postoperatively

  • Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)

    Percent FFM is calculated as (1-Percent Fat Mass) from DXA

    Baseline, 12 months postoperatively

  • Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry

    RMR from canopy indirect calorimetry

    Baseline, 12 months postoperatively

  • Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor

    Mean 24 hour systolic BP

    Baseline, 12 months postoperatively

  • Observational phase: Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram

    Resting supine 2-dimensional echocardiogram

    Baseline, 12 months postoperatively

  • Intervention phase: Change in BMI

    \[(BMI at 26 weeks-Weight at Intervention Baseline)\]/(BMI at Intervention Baseline)\] \* 100

    Baseline, 26 weeks

Secondary Outcomes (21)

  • Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels

    Baseline, 3 months postoperatively

  • Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels

    Baseline, 3 months postoperatively

  • Change in fasting Peptide YY (PYY), measured by blood levels

    Baseline, 3 months postoperatively

  • Change in fasting Peptide YY (PYY), measured by blood levels

    Baseline, 12 months postoperatively

  • Change in stimulated Peptide YY (PYY), measured by blood levels

    Baseline, 3 months postoperatively

  • +16 more secondary outcomes

Study Arms (3)

Observational

NO INTERVENTION

Participants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 12 months postoperatively.

Active Medication + Standard Postoperative Care

EXPERIMENTAL

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.

Drug: Injectable semaglutideBehavioral: Standard postoperative care

Standard Postoperative Care

ACTIVE COMPARATOR

Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care.

Behavioral: Standard postoperative care

Interventions

Injectable semaglutideDRUG

Subcutaneous weekly injectable semaglutide

Active Medication + Standard Postoperative Care
Standard postoperative careBEHAVIORAL

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.

Active Medication + Standard Postoperative CareStandard Postoperative Care

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • Surgically correctable cause of suboptimal postoperative weight loss
  • Known hypersensitivity to any component of semaglutide
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

ObesityPediatric ObesityBody-Weight Trajectory

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jaime Moore, MD MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Moore, MD MPH

CONTACT

303-724-8419jaime.moore@cuanschutz.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 28, 2024

Study Start

October 11, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(1)