Phentermine/Gastric Band Weight Loss Study

Wake Forest University Health Sciences

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Obesity

Interventions

PhentermineDRUG

Subjects will receive Phentermine 37.5mg everyday for one year

PlaceboOTHER

daily for one year

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Primary outcomes are total weight loss and excess weight

Time frame: one year

Secondary Outcomes

Secondary outcomes is resolution of preoperative comorbidities

Time frame: one year

Data from ClinicalTrials.gov

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