This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.
Although bariatric surgery is the most effective treatment for severe obesity, a large proportion of patients experience significant weight regain with longer follow-up. In this randomized controlled trial employing a SMART design, a total of 120 subjects with weight regain after bariatric surgery, will be initially randomized in a 3:3:2 ratio to daily treatment with topiramate (TPM) or phentermine (PHEN) or placebo. After 4 months, responders (those with ≥5% weight loss) will continue the same treatment, while nonresponders will be re-randomized to a higher dose of the same drug or phentermine/topiramate combination (PHEN/TPM) during Months 5-12. All subjects will receive diet and lifestyle counseling throughout the study. Aim 1: To determine whether pharmacotherapy can reverse post-bariatric surgery weight regain. Hypothesis: Compared to placebo, all three active drug therapies - TPM, PHEN, and PHEN/TPM will lead to greater percent weight loss at Month 12. Aim 2: To examine change in energy intake assessed by a dietitian interview. Hypothesis: Compared to placebo, active drug therapies will lead to greater reduction in energy intake at Month 12. Aim 3: To examine changes in the most common maladaptive eating behaviors in the post-bariatric surgery patients - grazing, loss-of-control eating, and binge eating. Hypothesis: Compared to placebo, active drug therapies will lead to decreased maladaptive eating behaviors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Topiramate is an anticonvulsant (antiepilepsy) drug. IUPAC ID: 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Phentermine belongs to a class of drugs called anorectics, also known as appetite suppressants. IUPAC name 2-methyl-1-phenylpropan-2-amine
Placebo is an inactive substance.
University of California Irvine Medical Center
Orange, California, United States
RECRUITINGPercent weight loss at Month 12 - Topiramate vs placebo
Topiramate (Group 1 \[Group A + Group B\]) vs placebo (Group P)
Time frame: Month 0, Month 12
Percent weight loss at Month 12 - Phentermine vs placebo
Phentermine (Group 2 \[Group D + Group E) vs placebo (Group P)
Time frame: Month 0, Month 12
Percent weight loss at Month 12 - Phentermine/Topiramate
Phentermine/Topiramate (Group 3 \[Group C + Group F\]) vs placebo (Group P)
Time frame: Month 0, Month 12
Energy intake
Change in energy intake in kcal/d assessed with a dietitian interview. Comparisons between Groups 1, 2, 3 vs placebo.
Time frame: Month 0, Month 12
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