Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study
Who is this study for? Adolescents and young adults with inadequate weight loss after vertical sleeve gastrectomy
What treatments are being studied? Topiramate+Phentermine
Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 25
Healthy Volunteers: f
View:
• Surgical patients in the LPCH/Stanford bariatric and weight management clinics
• Inadequate weight loss after vertical sleeve gastrectomy
Locations
United States
California
Stanford University
Palo Alto
Time Frame
Start Date: 2022-06
Completion Date: 2022-06
Treatments
Experimental: Medication Group
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.
No_intervention: Non-Medication Group
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.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Maternal and Child Health Research Institute
Leads: Janey Pratt