Medications After Adolescent Bariatric Surgery

NCT04572217 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 549671092951-100- KHAAX
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Adolescent; Bariatric Surgery; Medications; Weight loss

Outcome Measures

Primary Outcomes (1)

• Number of participants who are able to consent for off-label medication use as a measure of feasibility

  Up to 1 year

Secondary Outcomes (5)

• Average daily rate of compliance with medication administration

  Up to 1 year

• Percent change from baseline in % BMI

  Baseline (initiation of medication), 1 year

• Type of weight loss medication prescribed

  Up to 1 year

• Number of participants experiencing side effects

  Up to 1 year

• Timing of the implementation of off-label medications after vertical sleeve gastrectomy

  Up to 1 year

Study Arms (2)

Medication Group

EXPERIMENTAL

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.

Drug: Topiramate; Drug: Phentermine

Non-Medication Group

NO INTERVENTION

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.

Interventions

Topiramate DRUG

Topiramate (starting dose 25 mg daily, max dose 100 mg daily)

Medication Group

Phentermine DRUG

Phentermine (starting dose 8 mg, max dose 16 mg)

Medication Group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Surgical patients in the LPCH/Stanford bariatric and weight management clinics
• Inadequate weight loss after vertical sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Janey Pratt: lead
• Maternal and Child Health Research Institute: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (12)

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  PMID: 12681003 BACKGROUND

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  PMID: 12532161 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Weight Loss

Interventions

Topiramate; Phentermine

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Janey Pratt, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor of Surgery

Model Details: Pilot feasibility study

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: June 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)