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PROJECT-BARI

UCI Specialty Area: Cardiology
Principal Investigator: Kishore Gadde
Official Title: Pharmacotherapy in conjunction with lifestyle counseling for management of weight regain after bariatric surgery (PROJECT-BARI)
A Study On:
Heart - Cardiovascular Circulatory
Obesity

Study Description

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) 50 mg or phentermine (PHEN) 7.5 mg 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 7.5/50 mg 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.

Eligibility

  1. Male and female subjects aged 18-70 years
  2. Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) between ≥18 months and less than or equal to 10 years ago
  3. Weight regain of greater than or equal to 5% relative to post-surgery nadir weight
  4. Body mass index (BMI) >/=30 kg/m2 or >/= 27 kg/m2 with weight-related comorbidities
  5. Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry
  6. Must be able to provide written informed consent
  1. Type 1 diabetes
  2. Insulin-dependent type 2 diabetes
  3. Fasting plasma glucose (FPG) >/= 240 mg/dL
  4. Uncontrolled hypertension defined as systolic blood pressure (SBP) >/= 150 mm Hg and/or diastolic blood pressure (DBP) >/= 100 mm Hg on the average of three seated measurements after being at rest for at least 5 minutes
  5. History of significant (as determined by the investigator) and unstable cardiovascular disease including coronary artery disease, arrhythmias, severe congestive heart failure, or stroke
  6. Use of monoamine oxidase inhibitors, current or within 2 weeks
  7. Hyperthyroidism or other significant thyroid disease
  8. Angle-closure glaucoma
  9. Agitated states
  10. History of drug abuse within the past year
  11. Known hypersensitivity or idiosyncrasy to sympathomimetic amines
  12. Severe hepatic disease (non-alcoholic fatty liver disease or non-alcoholic steatohepatitis without portal hypertension or cirrhosis is acceptable)
  13. End-stage renal disease
  14. History of nephrolithiasis
  15. Serum triglycerides ≥500 mg/dL
  16. Cancer, not in remission, within the past 2 years except for adequately treated basal cell, squamous cell skin cancer, or in-situ cervical cancer
  17. History of psychosis or bipolar disorder
  18. Suicidal ideation or unstable/untreated major depressive disorder within the past year
  19. Use of antidepressant medication that has not been at stable dose for at least 3 months
  20. Hospital Anxiety and Depression Scale (HADS) score of ≥11 for depression or anxiety items
  21. Binge Eating Scale (BES) score of >/= 27
  22. Alcohol use disorder within the past year
  23. Epilepsy
  24. Currently taking phentermine or topiramate or the combination, or products containing these drugs
  25. Currently taking stimulants (e.g., Attention Deficit Hyperactivity Disorder medications)
  26. Current use of prescription or over-the-counter weight loss drugs or supplements
  27. Taking prescription or over-the-counter drugs or products, which in the opinion of the PI, could be associated with significant effects on body weight
  28. Planning additional bariatric surgery procedures in the next 13 months
  29. History of revisional bariatric surgery (revisional surgery after adjustable gastric banding is acceptable)
  30. Currently participating in another weight loss program or have plans to participate in the next 13 months
  31. Smoking cessation within the previous 3 months or plans to quit smoking in the next 13 months
  32. Pregnant or breastfeeding or planning pregnancy in the coming 13 months
  33. History of, or any existing condition that, in the opinion of the Principal Investigator, would interfere with the study outcomes or place the subject at unacceptable risk by participating in the study
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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