Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Aug 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well medication, combined with lifestyle counseling, can help people who have regained weight after having weight-loss surgery, like sleeve gastrectomy or gastric bypass. The study is specifically for adults aged 18 to 70 who had one of these surgeries at least 18 months ago but less than 10 years ago and have gained back at least 5% of their lowest post-surgery weight. Participants should have a body mass index (BMI) of 30 or more, or 27 or more if they have other weight-related health issues.

If you qualify and choose to participate, you will receive both medication and counseling to support healthy lifestyle changes. The trial is currently recruiting participants, so it’s a good opportunity for those struggling with weight regain to get help in a structured setting. However, there are specific health conditions that might prevent someone from joining, such as certain types of diabetes or cardiovascular issues, so it’s important to talk to the study team to see if you’re eligible.

Gender

ALL

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