Health TrialsbyHealthPanel

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

ConditionObesity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Group A: Topiramate 50 mgExperimental treatment 1 intervention
Group B: Group B: Topiramate 100 mgExperimental treatment 1 intervention
Group C: Group C: Phentermine 15 mg/Topiramate 100 mgExperimental treatment 2 interventions
Group D: Group D: Phentermine 15 mgExperimental treatment 1 intervention
Group E: Group E: Phentermine 30 mgExperimental treatment 1 intervention
Group F: Group F: Phentermine 15 mg/Topiramate 100 mgExperimental treatment 2 interventions
Group G: Group P: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent weight loss at Month 12 - Topiramate vs placebo

Topiramate (Group 1 \[Group A + Group B\]) vs placebo (Group P)

Time frame
Month 0, Month 12
2

Percent weight loss at Month 12 - Phentermine vs placebo

Phentermine (Group 2 \[Group D + Group E) vs placebo (Group P)

Time frame
Month 0, Month 12
3

Percent weight loss at Month 12 - Phentermine/Topiramate

Phentermine/Topiramate (Group 3 \[Group C + Group F\]) vs placebo (Group P)

Time frame
Month 0, Month 12

Secondary outcomes

1

Energy intake

Change in energy intake in kcal/d assessed with a dietitian interview. Comparisons between Groups 1, 2, 3 vs placebo.

Time frame
Month 0, Month 12

Other outcomes

1

Grazing

Change in grazing behavior, assessed with the Grazing Questionnaire. Comparisons between Groups 1, 2, 3 vs placebo.

Time frame
Months 0, 4, 12
2

Loss-of-control eating

Change in loss-of-control eating, assessed with the Loss-of-Control Eating Scale. Comparisons between Groups 1, 2, 3 vs placebo.

Time frame
Months 0, 4, 12
3

Binge eating

Change in binge eating, assessed with the Binge Eating Scale. Comparisons between Groups 1, 2, 3 vs placebo.

Time frame
Months 0, 4, 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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