Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by Kishore M Gadde, MD

Description

Summary

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.

Details

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.

Keywords

Obesity, Bariatric surgery, Weight regain, Antiobesity drugs, Treatment of weight regain, Topiramate, Phentermine, Topiramate 50 mg, Topiramate 100 mg, Phentermine 7.5 mg/Topiramate 50 mg, Phentermine 7.5 mg, Phentermine 15 mg

Eligibility

You can join if…

Open to people ages 18-70

  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 ≤10 years ago
  3. Weight regain of ≥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

You CAN'T join if...

  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

Location

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05975580
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated