- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572217
Medications After Adolescent Bariatric Surgery (MAABS Protocol)
Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Topiramate (starting dose 25 mg daily, max dose 100 mg daily)
Phentermine (starting dose 8 mg, max dose 16 mg)
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants who are able to consent for off-label medication use as a measure of feasibility
Time Frame: Up to 1 year
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average daily rate of compliance with medication administration
Time Frame: Up to 1 year
|
Up to 1 year
|
|
Percent change from baseline in % BMI
Time Frame: Baseline (initiation of medication), 1 year
|
Baseline (initiation of medication), 1 year
|
|
Type of weight loss medication prescribed
Time Frame: Up to 1 year
|
Type of weight loss medication prescribed, according to type and dose
|
Up to 1 year
|
Number of participants experiencing side effects
Time Frame: Up to 1 year
|
Up to 1 year
|
|
Timing of the implementation of off-label medications after vertical sleeve gastrectomy
Time Frame: Up to 1 year
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Janey Pratt, MD, Stanford University
Publications and helpful links
General Publications
- Hendricks EJ, Srisurapanont M, Schmidt SL, Haggard M, Souter S, Mitchell CL, De Marco DG, Hendricks MJ, Istratiy Y, Greenway FL. Addiction potential of phentermine prescribed during long-term treatment of obesity. Int J Obes (Lond). 2014 Feb;38(2):292-8. doi: 10.1038/ijo.2013.74. Epub 2013 May 17.
- Aldenkamp AP, Baker G, Mulder OG, Chadwick D, Cooper P, Doelman J, Duncan R, Gassmann-Mayer C, de Haan GJ, Hughson C, Hulsman J, Overweg J, Pledger G, Rentmeester TW, Riaz H, Wroe S. A multicenter, randomized clinical study to evaluate the effect on cognitive function of topiramate compared with valproate as add-on therapy to carbamazepine in patients with partial-onset seizures. Epilepsia. 2000 Sep;41(9):1167-78. doi: 10.1111/j.1528-1157.2000.tb00322.x.
- Boyer EW, Shannon M. The serotonin syndrome. N Engl J Med. 2005 Mar 17;352(11):1112-20. doi: 10.1056/NEJMra041867. No abstract available. Erratum In: N Engl J Med. 2007 Jun 7;356(23):2437. N Engl J Med. 2009 Oct 22;361(17):1714.
- Chanoine JP, Richard M. Early weight loss and outcome at one year in obese adolescents treated with orlistat or placebo. Int J Pediatr Obes. 2011 Apr;6(2):95-101. doi: 10.3109/17477166.2010.519387. Epub 2010 Sep 22.
- Czepiel KS, Perez NP, Campoverde Reyes KJ, Sabharwal S, Stanford FC. Pharmacotherapy for the Treatment of Overweight and Obesity in Children, Adolescents, and Young Adults in a Large Health System in the US. Front Endocrinol (Lausanne). 2020 May 13;11:290. doi: 10.3389/fendo.2020.00290. eCollection 2020.
- Doose DR, Wang SS, Padmanabhan M, Schwabe S, Jacobs D, Bialer M. Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. Epilepsia. 2003 Apr;44(4):540-9. doi: 10.1046/j.1528-1157.2003.55602.x.
- Kramer CK, Leitao CB, Pinto LC, Canani LH, Azevedo MJ, Gross JL. Efficacy and safety of topiramate on weight loss: a meta-analysis of randomized controlled trials. Obes Rev. 2011 May;12(5):e338-47. doi: 10.1111/j.1467-789X.2010.00846.x. Epub 2011 Mar 28.
- Lewis KH, Fischer H, Ard J, Barton L, Bessesen DH, Daley MF, Desai J, Fitzpatrick SL, Horberg M, Koebnick C, Oshiro C, Yamamoto A, Young DR, Arterburn DE. Safety and Effectiveness of Longer-Term Phentermine Use: Clinical Outcomes from an Electronic Health Record Cohort. Obesity (Silver Spring). 2019 Apr;27(4):591-602. doi: 10.1002/oby.22430.
- Ahamada Safna Mariyam M, Sen S, Vijayan K. Topiramate: Safety in migraine patients. J Young Pharm. 2013 Mar;5(1):30-1. doi: 10.1016/j.jyp.2012.12.001. Epub 2013 Mar 6. No abstract available.
- Martin R, Kuzniecky R, Ho S, Hetherington H, Pan J, Sinclair K, Gilliam F, Faught E. Cognitive effects of topiramate, gabapentin, and lamotrigine in healthy young adults. Neurology. 1999 Jan 15;52(2):321-7. doi: 10.1212/wnl.52.2.321.
- Rich S, Rubin L, Walker AM, Schneeweiss S, Abenhaim L. Anorexigens and pulmonary hypertension in the United States: results from the surveillance of North American pulmonary hypertension. Chest. 2000 Mar;117(3):870-4. doi: 10.1378/chest.117.3.870.
- Rissanen A, Lean M, Rossner S, Segal KR, Sjostrom L. Predictive value of early weight loss in obesity management with orlistat: an evidence-based assessment of prescribing guidelines. Int J Obes Relat Metab Disord. 2003 Jan;27(1):103-9. doi: 10.1038/sj.ijo.0802165.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Pediatric Obesity
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anticonvulsants
- Appetite Depressants
- Anti-Obesity Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Topiramate
- Phentermine
Other Study ID Numbers
- 54967
- 1092951-100- KHAAX (Other Grant/Funding Number: MCHRI Clinical Fellowship Grant)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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