Phentermine/Gastric Band Weight Loss Study
- Registration Number
- NCT00771654
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
This is a prospective, randomized, double-blind controlled trial. The goal is to show whether the administration of daily oral Phentermine will augment patient weight loss and resolve obesity associated comorbidities following gastric band operation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult age 18-65
- BMI 35-55
- Approved for gastric band operation
Exclusion Criteria
- A known allergy to Phentermine
- Take medications for Attention Deficit Disorder (ADD)
- Monoamine oxidase inhibitors (MAOI)for depression
- Selective serotonin reuptake inhibitor (SSRIs)for depression
- History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias
- Hyperthyroidism
- Glaucoma
- Psychosis
- History of drug abuse
- Uncontrolled hypertension (diastolic >85)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure Phentermine Phentermine Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure
- Primary Outcome Measures
Name Time Method Primary outcomes are total weight loss and excess weight one year
- Secondary Outcome Measures
Name Time Method Secondary outcomes is resolution of preoperative comorbidities one year