Medications After Adolescent Bariatric Surgery

Pediatric Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04572217
• Other study ID #: 54967
• Secondary ID: 1092951-100- KHA
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2022
• Est. completion date: June 2022

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Drug:
• Topiramate
Topiramate (starting dose 25 mg daily, max dose 100 mg daily)
• Phentermine
Phentermine (starting dose 8 mg, max dose 16 mg)

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Janey Pratt	Maternal and Child Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

Boyer EW, Shannon M. The serotonin syndrome. N Engl J Med. 2005 Mar 17;352(11):1112-20. Review. Erratum in: N Engl J Med. 2007 Jun 7;356(23):2437. N Engl J Med. 2009 Oct 22;361(17):1714. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kramer CK, Leitão 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rissanen A, Lean M, Rössner S, Segal KR, Sjöström 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who are able to consent for off-label medication use as a measure of feasibility		Up to 1 year
Secondary	Average daily rate of compliance with medication administration		Up to 1 year
Secondary	Percent change from baseline in % BMI		Baseline (initiation of medication), 1 year
Secondary	Type of weight loss medication prescribed	Type of weight loss medication prescribed, according to type and dose	Up to 1 year
Secondary	Number of participants experiencing side effects		Up to 1 year
Secondary	Timing of the implementation of off-label medications after vertical sleeve gastrectomy		Up to 1 year