Qsymia as an Adjunct to Surgical Therapy in the Superobese

Study Overview
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Brief Summary
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This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. Individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.

Detailed Description
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While there is obvious focus on the obesity epidemic that affects approximately one-third of the U.S. population, one subgroup within the epidemic remains on the fringe of scientific study and effective treatment options. The super obese patient, in this instance defined as those with a BMI ≥ 50 kg/m2, presents a difficult treatment challenge in managing this level of obesity. While bariatric surgery, including Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch, have been shown to be effective in severe obesity (BMI ≥ 40 kg/m2), the risks involved with surgical intervention in the super obese patient are high. Qsymia provides a potential opportunity to develop an effective treatment plan that would be an adjunct to surgical intervention in the super obese patient. Use of Qsymia in addition to a low-calorie dietary prescription pre-operatively would effectively decrease weight prior to surgical intervention, lowering surgical risk to some extent. Additionally, if continued post-operatively, Qsymia as an adjunct to the post-surgical dietary plan would potentially extend the weight loss horizon so that the probability of the typical weight loss plateau at 12-18 months is decreased.

Official Title
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Qsymia as an Adjunct to Surgical Therapy in the Superobese

Conditions
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Obesity, Metabolic Surgery, Weight Loss, Bariatric Surgery Procedures

Intervention / Treatment
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* Drug: Phentermine/topiramate
* Other: low calorie diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 50 kg/m2 Determined to be a good candidate for surgery based on medical and psychological exam. Willing to participate in a 3-6 month medically supervised weight loss plan prior to surgery. Planning to remain in the reasonable vicinity of the Wake Forest Baptist Health - Weight Management Center for the duration of the study. Exclusion Criteria: History of prior weight loss surgery (removal/conversion from band to sleeve will not be excluded) Pregnant (women of childbearing potential will complete a pregnancy test (blood draw) to make sure they are not pregnant at the time that they initiate the medication). Ongoing monitoring of pregnancy status is the responsibility of the patient and they are instructed as such in the consent form. Ongoing use of weight loss medication Contraindications to use of Qsymia, including pregnancy, history of glaucoma, unstable cardiac disease (unstable angina, recent heart attack or stroke (in the past 6 months), uncontrolled arrhythmia), hyperthyroidism, taking monoamine oxidase inhibitors (MAOIs) or allergy to either topiramate or sympathomimetic amines like phentermine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phentermine/topiramate<br>All subjects enrolled in the study will be placed on the study medication. | Drug: Phentermine/topiramate<br>* Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery.<br>* Other names: Qsymia;Other: low calorie diet<br>* The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.<br>|
| No Intervention: Historical Control<br>Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) | Proportion of patients who do not meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia. The criteria that suggest RYGB is indicated are: 1) BMI of 40 or greater or 2) BMI of 35-39.9 with poorly controlled co-morbidities. | 24 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 24 months post-operatively | 
| Body Mass Index | Resulting body mass index | 24 months post-operatively | 
| Percent Body Fat | Change in percent body fat | 24 months post-operatively | 
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 24 months post-operatively | 
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 12 months post-operatively | 
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 6 months post-operatively | 
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 3 months post-operatively | 
| Body Mass Index | Resulting body mass index | 12 months post-operatively | 
| Body Mass Index | Resulting body mass index | 6 months post-operatively | 
| Body Mass Index | Resulting body mass index | 3 months post-operatively | 
| Percent Body Fat | Change in percent body fat | 12 months post-operatively | 
| Percent Body Fat | Change in percent body fat | 6 months post-operatively | 
| Percent Body Fat | Change in percent body fat | 3 months post-operatively | 
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 12 months post-operatively | 
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 6 months post-operatively | 
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 3 months post-operatively |