Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Aim 2: To examine change in energy intake assessed by a dietitian interview."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether medicine plus counseling on lifestyle habits can help reverse weight gain after weight-loss surgery. It is for adults ages 18–70 who have gained back weight after a sleeve gastrectomy or Roux-en-Y gastric bypass.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–70 years old.
- You had a sleeve gastrectomy or Roux-en-Y gastric bypass at least 18 months ago. These are types of weight-loss surgery.
- You have gained back at least 5% of your lowest weight after surgery.
- Your body mass index (BMI), a measure based on height and weight, is at least 30, or at least 27 with weight-related health problems.
- If you can become pregnant, you must use birth control during the study and have a negative pregnancy test when you join.
- You can give written consent to join the study.
Who can't join
- You have type 1 diabetes, type 2 diabetes treated with insulin, or fasting blood sugar of 240 mg/dL or higher.
- Your blood pressure averages 150 or higher for the top number or 100 or higher for the bottom number over three seated readings after resting.
- You have serious, unstable heart or blood vessel disease, certain thyroid or eye diseases, severe liver disease, kidney failure, past kidney stones, or epilepsy.
- You have certain mental health conditions, recent drug or alcohol abuse, or high scores on anxiety, depression, or binge-eating tests.
- You take certain medicines, including stimulants, phentermine, topiramate, or weight-loss drugs or supplements. Some other medicines and drug reactions also rule out joining.
- You plan more weight-loss surgery or another weight-loss program in the next 13 months, or you are already in another weight-loss program. Some past repeat weight-loss surgeries also rule out joining.
- You are pregnant, breastfeeding, or planning pregnancy in the next 13 months. You also cannot join if you quit smoking in the past 3 months or plan to quit in the next 13 months.
- Other limits include certain recent cancers, very high blood fats called triglycerides, and any condition the study doctor believes would make joining unsafe or affect the results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Male and female subjects aged 18-70 years 2. Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least 18 months 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 Exclusion Criteria: 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
Study sites (1)
CA
- University of California Irvine Medical Center · Orange, CA 92868Raha Esmaeili · Study contact · rahae@hs.uci.eduMelanie Morales Vargas · Study contact · msmoral2@hs.uci.eduKishore M Gadde, MD · Principal investigatorMore trials in Orange