Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT02301416
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Qsymia
The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
Time frame: 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.
Time frame: Pre-operatively and 24 months post-operatively
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: 24 months post-operatively
Resulting body mass index
Time frame: 24 months post-operatively
Change in percent body fat
Time frame: 24 months post-operatively
Resting metabolic rate via indirect calorimetry
Time frame: Pre-operatively and 12 months post-operatively
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: Pre-operatively and 6 months post-operatively
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: Pre-operatively and 3 months post-operatively
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time frame: 12 months post-operatively
Resulting body mass index
Time frame: 6 months post-operatively
Resulting body mass index
Time frame: 3 months post-operatively
Resulting body mass index
Time frame: 12 months post-operatively
Change in percent body fat
Time frame: 6 months post-operatively
Change in percent body fat
Time frame: 3 months post-operatively
Change in percent body fat
Time frame: 12 months post-operatively
Resting metabolic rate via indirect calorimetry
Time frame: 6 months post-operatively
Resting metabolic rate via indirect calorimetry
Time frame: 3 months post-operatively
Resting metabolic rate via indirect calorimetry
Wake Forest University Health Sciences
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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