Overview

Medications After Adolescent Bariatric Surgery

Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janey Pratt
Collaborator:
Maternal and Child Health Research Institute
Treatments:
Phentermine
Topiramate
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