Clinical trial NCT02301416: Qsymia as an Adjunct to Surgical Therapy in the Superobese
Official title: Qsymia as an Adjunct to Surgical Therapy in the Superobese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Metabolic Surgery
Weight Loss
Bariatric Surgery Procedures
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: VIVUS LLC
First posted: 2014-11-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

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

Primary outcomes:
measure: Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)
timeFrame: 24 months post-operatively
Secondary outcomes:
measure: Percent Weight Change
timeFrame: Pre-operatively and 24 months post-operatively
measure: Body Mass Index
timeFrame: 24 months post-operatively
measure: Percent Body Fat
timeFrame: 24 months post-operatively
measure: Resting Metabolic Rate
timeFrame: 24 months post-operatively
measure: Percent Weight Change
timeFrame: Pre-operatively and 12 months post-operatively
measure: Percent Weight Change
timeFrame: Pre-operatively and 6 months post-operatively
measure: Percent Weight Change
timeFrame: Pre-operatively and 3 months post-operatively
measure: Body Mass Index
timeFrame: 12 months post-operatively
measure: Body Mass Index
timeFrame: 6 months post-operatively
measure: Body Mass Index
timeFrame: 3 months post-operatively
measure: Percent Body Fat
timeFrame: 12 months post-operatively
measure: Percent Body Fat
timeFrame: 6 months post-operatively
measure: Percent Body Fat
timeFrame: 3 months post-operatively
measure: Resting Metabolic Rate
timeFrame: 12 months post-operatively
measure: Resting Metabolic Rate
timeFrame: 6 months post-operatively
measure: Resting Metabolic Rate
timeFrame: 3 months post-operatively
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jamy D Ard, MD
role: PRINCIPAL_INVESTIGATOR
References: