Clinical trial NCT04572217: Medications After Adolescent Bariatric Surgery
Official title: Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pediatric Obesity
Keywords: Adolescent
Bariatric Surgery
Medications
Weight loss
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Maternal and Child Health Research Institute
First posted: 2020-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot feasibility study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants who are able to consent for off-label medication use as a measure of feasibility
timeFrame: Up to 1 year
Secondary outcomes:
measure: Average daily rate of compliance with medication administration
timeFrame: Up to 1 year
measure: Percent change from baseline in % BMI
timeFrame: Baseline (initiation of medication), 1 year
measure: Type of weight loss medication prescribed
timeFrame: Up to 1 year
measure: Number of participants experiencing side effects
timeFrame: Up to 1 year
measure: Timing of the implementation of off-label medications after vertical sleeve gastrectomy
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Janey Pratt, MD
role: PRINCIPAL_INVESTIGATOR
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