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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT05975580
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Topiramate — DRUG
    Topiramate is an anticonvulsant (antiepilepsy) drug. IUPAC ID: 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
  • Phentermine — DRUG
    Phentermine belongs to a class of drugs called anorectics, also known as appetite suppressants. IUPAC name 2-methyl-1-phenylpropan-2-amine
  • Placebo — DRUG
    Placebo is an inactive substance.

Study Details

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.

Key Dates

Start date
Aug 29, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Topiramate 50 mg
    Topiramate will be started at 25 mg daily and the dose will be increased to 50 mg daily after 15 days. Responders at Month 4 will continue the same treatment until Month 12.
  • Experimental: Group B: Topiramate 100 mg
    Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 15/100 mg during Months 5-12. Doses will be titrated in Month 5.
  • Experimental: Group C: Phentermine 15 mg/Topiramate 100 mg
    Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 15/100 mg during Months 5-12. Doses will be titrated in Month 5.
  • Experimental: Group D: Phentermine 15 mg
    Phentermine will be started at 7.5 mg daily and the dose will be increased to 15 mg after 15 days. Responders at Month 4 will continue the same treatment until Month 12.
  • Experimental: Group E: Phentermine 30 mg
    Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 30 mg or phentermine/topiramate 15/100 mg during Months 5-12. Doses will be titrated in Month 5.
  • Experimental: Group F: Phentermine 15 mg/Topiramate 100 mg
    Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 30 mg or phentermine/topiramate 15/100 mg during Months 5-12. Doses will be titrated in Month 5.
  • Placebo Comparator: Group P: Placebo
    Placebo group will receive placebo.

Primary Outcome Measure

Percent weight loss at Month 12 - Topiramate vs placebo [ Time Frame: Month 0, Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterOrangeCalifornia92868
Phuong Linh Huynh, MPH
[email protected]
714-456-6155
Qin Wang
[email protected]
Kishore M Gadde, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of California Irvine Medical Center· Orange, CA

Related Studies