Overview
Medications After Adolescent Bariatric Surgery
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-06-01
2022-06-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janey PrattCollaborator:
Maternal and Child Health Research InstituteTreatments:
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