Bariatric Surgery Procedures, Metabolic Surgery, Obesity, Weight Loss
Conditions
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.
Interventions
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.
OTHERlow calorie diet
The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
Sponsors
VIVUS LLC
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) | 24 months post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change | Pre-operatively and 24 months post-operatively | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. |
| Body Mass Index | 24 months post-operatively | Resulting body mass index |
| Percent Body Fat | 24 months post-operatively | Change in percent body fat |
| Resting Metabolic Rate | 24 months post-operatively | Resting metabolic rate via indirect calorimetry |
Countries
United States
Participant flow
Recruitment details
Retrospective chart review patients were not considered enrolled, but historical data was used as a comparison so it is included.
Participants by arm
| Arm | Count |
|---|---|
| Phentermine/Topiramate All subjects enrolled in the study will be placed on the study medication.
Phentermine/topiramate: 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. | 15 |
| Surgery Only Historical controls who had sleeve gastrectomy without phentermine/topiramate | 40 |
| Total | 55 |
Baseline characteristics
| Characteristic | Phentermine/Topiramate | Surgery Only | Total |
|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 7.3 | 45 years STANDARD_DEVIATION 10.8 | 44.6 years STANDARD_DEVIATION 10 |
| Body mass index | 61.2 kg/m^2 STANDARD_DEVIATION 7.1 | 57 kg/m^2 STANDARD_DEVIATION 5.6 | 58.1 kg/m^2 STANDARD_DEVIATION 6.3 |
| Body weight | 178.9 kilograms STANDARD_DEVIATION 31.1 | 159.5 kilograms STANDARD_DEVIATION 21 | 164.8 kilograms STANDARD_DEVIATION 25.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 40 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 03 Participants | 9 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 31 Participants | 43 Participants |
| Region of Enrollment United States | 15 participants | 40 participants | 55 participants |
| Sex: Female, Male Female | 12 Participants | 33 Participants | 45 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 3 / 25 |
| serious Total, serious adverse events | 2 / 25 |
Outcome results
Primary
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.
Time frame: 24 months post-operatively
Population: 2 participants had RYGB instead of Sleeve Gastrectomy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phentermine/Topiramate | Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) | 8 Participants |
| Surgery Only | Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) | 19 Participants |
Secondary
Body Mass Index
Resulting body mass index
Time frame: 24 months post-operatively
Population: 2 participants had RYGB instead of Sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Body Mass Index | 33.79 kg/m^2 |
| Surgery Only | Body Mass Index | 41.96 kg/m^2 |
Secondary
Body Mass Index
Resulting body mass index
Time frame: 12 months post-operatively
Population: 2 participants had RYGB instead of Sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Body Mass Index | 33.46 kg/m^2 |
| Surgery Only | Body Mass Index | 39.53 kg/m^2 |
Secondary
Body Mass Index
Resulting body mass index
Time frame: 6 months post-operatively
Population: 2 participants had RYGB instead of Sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Body Mass Index | 37.61 kg/m^2 |
| Surgery Only | Body Mass Index | 41.93 kg/m^2 |
Secondary
Body Mass Index
Resulting body mass index
Time frame: 3 months post-operatively
Population: 2 participants had RYGB instead of Sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Body Mass Index | 42.31 kg/m^2 |
| Surgery Only | Body Mass Index | 45.28 kg/m^2 |
Secondary
Percent Body Fat
Change in percent body fat
Time frame: 24 months post-operatively
Population: Measure not obtained
Secondary
Percent Body Fat
Change in percent body fat
Time frame: 3 months post-operatively
Population: Measure not obtained
Secondary
Percent Body Fat
Change in percent body fat
Time frame: 12 months post-operatively
Population: Measure not obtained
Secondary
Percent Body Fat
Change in percent body fat
Time frame: 6 months post-operatively
Population: Measure not obtained
Secondary
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: Pre-operatively and 12 months post-operatively
Population: 2 participants had RYGB instead of sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Percent Weight Change | -39.34 Percent |
| Surgery Only | Percent Weight Change | -31.43 Percent |
Secondary
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: Pre-operatively and 6 months post-operatively
Population: 2 participants had RYGB instead of sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Percent Weight Change | -32.79 Percent |
| Surgery Only | Percent Weight Change | -27.25 Percent |
Secondary
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: Pre-operatively and 3 months post-operatively
Population: 2 participants had RYGB instead of sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Percent Weight Change | -25.24 Percent |
| Surgery Only | Percent Weight Change | -21.46 Percent |
Secondary
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: Pre-operatively and 24 months post-operatively
Population: 2 participants had RYGB instead of sleeve gastrectomy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine/Topiramate | Percent Weight Change | -38.16 Percentage of weight change |
| Surgery Only | Percent Weight Change | -27 Percentage of weight change |
Secondary
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Time frame: 3 months post-operatively
Population: Outcome measure not obtained
Secondary
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Time frame: 12 months post-operatively
Population: Outcome measure not obtained
Secondary
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Time frame: 6 months post-operatively
Population: Outcome measure not obtained
Secondary
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Time frame: 24 months post-operatively
Population: Outcome measure not obtained