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Medications After Adolescent Bariatric Surgery (MAABS Protocol)

Primary Purpose

Pediatric Obesity

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Topiramate

Phentermine

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Adolescent, Bariatric Surgery, Medications, Weight loss

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medication Group

Non-Medication Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Average daily rate of compliance with medication administration

Percent change from baseline in % BMI

Type of weight loss medication prescribed

Type of weight loss medication prescribed, according to type and dose

Number of participants experiencing side effects

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

Full Information

NCT ID

NCT04572217

First Posted

September 25, 2020

Last Updated

May 19, 2022

Sponsor

Janey Pratt

Collaborators

Maternal and Child Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04572217

Brief Title

Medications After Adolescent Bariatric Surgery

Acronym

MAABS Protocol

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Withdrawn

Why Stopped

No available funding

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Janey Pratt

Collaborators

Maternal and Child Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Obesity

Keywords

Adolescent, Bariatric Surgery, Medications, Weight loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Pilot feasibility study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medication Group

Arm Type

Experimental

Arm Description

Arm Title

Non-Medication Group

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Topiramate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Phentermine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 1 year

Secondary Outcome Measure Information:

Title

Average daily rate of compliance with medication administration

Time Frame

Up to 1 year

Title

Percent change from baseline in % BMI

Time Frame

Baseline (initiation of medication), 1 year

Title

Type of weight loss medication prescribed

Description

Type of weight loss medication prescribed, according to type and dose

Time Frame

Up to 1 year

Title

Number of participants experiencing side effects

Time Frame

Up to 1 year

Title

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

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janey Pratt, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Medications After Adolescent Bariatric Surgery

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