Actively Recruiting
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
Led by University of California, Irvine · Updated on 2026-02-17
120
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18-70 years
- Had sleeve gastrectomy or Roux-en-Y gastric bypass at least 18 months ago
- Weight regain of 5% or more relative to post-surgery lowest weight
- Body mass index (BMI) of 30 kg/m2 or above, or 27 kg/m2 or above with weight-related health conditions
- Women of childbearing potential must use contraception and have a negative pregnancy test at study entry
- Able to provide written informed consent
You will not qualify if you...
- Type 1 diabetes
- Insulin-dependent type 2 diabetes
- Fasting plasma glucose 240 mg/dL or higher
- Uncontrolled high blood pressure (systolic 150 mm Hg or more, diastolic 100 mm Hg or more)
- History of unstable or serious heart disease or stroke
- Use of monoamine oxidase inhibitors currently or within 2 weeks
- Hyperthyroidism or significant thyroid disease
- Angle-closure glaucoma
- Agitated states
- Drug abuse within the past year
- Allergic reaction or sensitivity to sympathomimetic amines
- Severe liver disease (fatty liver without portal hypertension or cirrhosis allowed)
- End-stage kidney disease
- History of kidney stones
- Serum triglycerides 500 mg/dL or higher
- Recent cancer not in remission (past 2 years), except certain skin or cervical cancers
- History of psychosis or bipolar disorder
- Suicidal thoughts or unstable major depression in past year
- Antidepressant use not stable for at least 3 months
- Hospital Anxiety and Depression Scale score 11 or higher for depression or anxiety
- Binge Eating Scale score 27 or higher
- Alcohol use disorder in past year
- Epilepsy
- Currently taking phentermine, topiramate, or both
- Currently taking stimulant medications
- Current use of weight loss drugs or supplements
- Use of drugs that may affect body weight as judged by the investigator
- Planning more bariatric surgery within 13 months
- History of revisional bariatric surgery (except after gastric banding)
- Participation in another weight loss program or plans to join one within 13 months
- Quit smoking within the past 3 months or plans to quit within 13 months
- Pregnant, breastfeeding, or planning pregnancy in next 13 months
- Any condition interfering with study or posing unacceptable risk as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
Research Team
P
Phuong Linh Huynh, MPH
CONTACT
Q
Qin Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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