Medications After Adolescent Bariatric Surgery (MAABS Protocol)

Janey Pratt

Status and phase: Withdrawn; Phase 2

Conditions: Pediatric Obesity

Treatments: Drug: Phentermine; Drug: Topiramate

Study type: Interventional

Funder types: Other

Identifiers

NCT04572217

54967

1092951-100- KHAAX (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Medication Group

Experimental group

Description:

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.

Treatment:

Drug: Topiramate

Drug: Phentermine

Non-Medication Group

No Intervention group

Description:

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.