Medications After Adolescent Bariatric Surgery

Phase 2

Withdrawn

• Conditions: Pediatric Obesity
• Interventions: Drug: Topiramate; Drug: Phentermine

• Registration Number: NCT04572217
• Lead Sponsor: Janey Pratt

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-26
• Study Start: 2022-06
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication Group	Phentermine	Adolescent patients post vertical sleeve gastrectomy who have had inadequate weight loss, who consented for use of off-label medications prescribed at the discretion (one or both) of physician. Patients will be followed every 2-12 weeks over one year. All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.
Medication Group	Topiramate	Adolescent patients post vertical sleeve gastrectomy who have had inadequate weight loss, who consented for use of off-label medications prescribed at the discretion (one or both) of physician. Patients will be followed every 2-12 weeks over one year. All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Timing of the implementation of off-label medications after vertical sleeve gastrectomy	Up to 1 year
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States