Status:
RECRUITING
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18-70 years
- Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least 18 months ago
- Weight regain of ≥5% relative to post-surgery nadir weight
- Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with weight-related comorbidities
- 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
- Must be able to provide written informed consent
Exclusion
- Type 1 diabetes
- Insulin-dependent type 2 diabetes
- Fasting plasma glucose (FPG) ≥240 mg/dL
- 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
- History of significant (as determined by the investigator) and unstable cardiovascular disease including coronary artery disease, arrhythmias, severe congestive heart failure, or stroke
- Use of monoamine oxidase inhibitors, current or within 2 weeks
- Hyperthyroidism or other significant thyroid disease
- Angle-closure glaucoma
- Agitated states
- History of drug abuse within the past year
- Known hypersensitivity or idiosyncrasy to sympathomimetic amines
- Severe hepatic disease (non-alcoholic fatty liver disease or non-alcoholic steatohepatitis without portal hypertension or cirrhosis is acceptable)
- End-stage renal disease
- History of nephrolithiasis
- Serum triglycerides ≥500 mg/dL
- Cancer, not in remission, within the past 2 years except for adequately treated basal cell, squamous cell skin cancer, or in-situ cervical cancer
- History of psychosis or bipolar disorder
- Suicidal ideation or unstable/untreated major depressive disorder within the past year
- Use of antidepressant medication that has not been at stable dose for at least 3 months
- Hospital Anxiety and Depression Scale (HADS) score of ≥11 for depression or anxiety items
- Binge Eating Scale (BES) score of ≥27
- Alcohol use disorder within the past year
- Epilepsy
- Currently taking phentermine or topiramate or the combination, or products containing these drugs
- Currently taking stimulants (e.g., Attention Deficit Hyperactivity Disorder medications)
- Current use of prescription or over-the-counter weight loss drugs or supplements
- 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
- Planning additional bariatric surgery procedures in the next 13 months
- History of revisional bariatric surgery (revisional surgery after adjustable gastric banding is acceptable)
- Currently participating in another weight loss program or have plans to participate in the next 13 months
- Smoking cessation within the previous 3 months or plans to quit smoking in the next 13 months
- Pregnant or breastfeeding or planning pregnancy in the coming 13 months
- 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
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05975580
Start Date
August 29 2023
End Date
July 31 2027
Last Update
January 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Irvine Medical Center
Orange, California, United States, 92868