Pharmacotherapy for Weight Regain After Bariatric Surgery
This study is looking at whether certain medications, along with healthy lifestyle advice, can help people who have regained weight after bariatric (weight loss) surgery. Researchers are testing two drugs, Topiramate and Phentermine, and a combination of both, against a placebo (an inactive substance). You might be able to join if you are between 18 and 70 years old, had sleeve gastrectomy or Roux-en-Y gastric bypass at least 18 months ago, and have regained at least 5% of your lowest weight after surgery. The main goal is to see if these medications lead to greater weight loss after 12 months compared to the placebo. The study is currently unclear on its recruitment status.
- Study design
- This is a randomized controlled trial with 120 participants. Participants will be initially assigned to receive Topiramate, Phentermine, or a placebo, and some may be re-assigned to different treatments later in the study.
- What's involved
- You would receive daily treatment with a study drug or placebo and participate in diet and lifestyle counseling throughout the 12-month study period. Weight loss will be measured at the beginning and at Month 12.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your weight loss will be measured at Month 12, which is the end of the treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kishore M Gadde, MD · PRINCIPAL_INVESTIGATOR · University of California, Irvine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Percent weight loss at Month 12 - Topiramate vs placeboMonth 0, Month 12
Topiramate (Group 1 \[Group A + Group B\]) vs placebo (Group P)
- Percent weight loss at Month 12 - Phentermine vs placeboMonth 0, Month 12
Phentermine (Group 2 \[Group D + Group E) vs placebo (Group P)
- Percent weight loss at Month 12 - Phentermine/TopiramateMonth 0, Month 12
Phentermine/Topiramate (Group 3 \[Group C + Group F\]) vs placebo (Group P)