RecruitingPhase 4

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

United States120 participantsStarted 2023-08-29

Plain-language 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 weight regain after bariatric surgery.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Percent weight loss at Month 12 - Topiramate vs placebo

Timeframe: Month 0, Month 12

Percent weight loss at Month 12 - Phentermine vs placebo

Timeframe: Month 0, Month 12

Percent weight loss at Month 12 - Phentermine/Topiramate

Timeframe: Month 0, Month 12

Trial details

NCT IDNCT05975580

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Phuong Linh Huynh, MPH

7144566155 plhuynh@hs.uci.edu

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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