Qsymia as an Adjunct to Surgical Therapy in the Superobese

Condition(s) targeted: Obesity; Metabolic Surgery; Weight Loss; Bariatric Surgery Procedures

Intervention: Phentermine/topiramate (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Jamy D Ard, MD, Principal Investigator, Affiliation: Wake Forest School of Medicine

Overall contact:
Erica R Hale, MS, Phone: 336-716-2236, Email: erosenbe@wakehealth.edu

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.

Official title: Qsymia as an Adjunct to Surgical Therapy in the Superobese

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Roux en Y Gastric Bypass

Secondary outcome:

Percent weight loss

Percent body fat

Resting Metabolic Rate

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 MAOIs (monoamine oxidase inhibitors) or allergy to either topiramate or sympathomimetic amines like phentermine.

Erica R Hale, MS, Phone: 336-716-2236, Email: erosenbe@wakehealth.edu

Wake Forest Baptist Health, Winston Salem, North Carolina 27157, United States; Recruiting

Starting date: December 2014
Last updated: June 22, 2015