Medications After Adolescent Bariatric Surgery

Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04572217

Acronym

MAABS Protocol

Enrollment

Registered

2020-10-01

Start date

2022-06-01

Completion date

2022-06-01

Last updated

2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

Adolescent, Bariatric Surgery, Medications, Weight loss

Brief summary

This study will assess the feasibility to assess practicality of early weight loss medication usage in adolescent patients post-VSG with inadequate weight loss. Participants who enroll in the study will be prescribed off-label use of weight loss medications for a period of up to 1 year.

Interventions

DRUGTopiramate

Topiramate (starting dose 25 mg daily, max dose 100 mg daily)

DRUGPhentermine

Phentermine (starting dose 8 mg, max dose 16 mg)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Pilot feasibility study

Eligibility

Sex/Gender

ALL

Age

12 Years to 25 Years

Healthy volunteers

Inclusion criteria

* Surgical patients in the LPCH/Stanford bariatric and weight management clinics * Inadequate weight loss after vertical sleeve gastrectomy

Exclusion criteria

* Adequate weight loss after surgery; * Unwilling to consent or adhere to safety monitoring plan; * Any life-threatening or terminal diseases * Currently pregnant, breastfeeding, or thinking of becoming pregnant * Allergy or medical contraindication to phentermine or topiramate; * History of drug or alcohol abuse; * No known medication interactions; * Significant renal or hepatic impairment; * Participation in a study of an investigational medication 30 days prior to screening, while the patient is on study, and for 30 days after their last dose of study treatment

Design outcomes

Primary

Measure	Time frame
Number of participants who are able to consent for off-label medication use as a measure of feasibility	Up to 1 year

Secondary

Measure	Time frame	Description
Average daily rate of compliance with medication administration	Up to 1 year	—
Percent change from baseline in % BMI	Baseline (initiation of medication), 1 year	—
Type of weight loss medication prescribed	Up to 1 year	Type of weight loss medication prescribed, according to type and dose
Number of participants experiencing side effects	Up to 1 year	—
Timing of the implementation of off-label medications after vertical sleeve gastrectomy	Up to 1 year	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026