Medications After Adolescent Bariatric Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Drug: Topiramate
* Drug: Phentermine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Group<br>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. | Drug: Topiramate<br>* Topiramate (starting dose 25 mg daily, max dose 100 mg daily)<br>Drug: Phentermine<br>* Phentermine (starting dose 8 mg, max dose 16 mg)<br>|
| No Intervention: Non-Medication Group<br>Adolescent patients post vertical sleeve gastrectomy who had inadequate weight loss and did not consent for use of off-label medications. 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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Type of weight loss medication prescribed, according to type and dose | Up to 1 year | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Bariatric Surgery, Medications, Weight loss