Qsymia as an Adjunct to Surgical Therapy in the Superobese
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Phentermine/topiramate
All subjects enrolled in the study will be placed on the study medication.
干预措施: Phentermine/topiramate (Drug)
Phentermine/topiramate
All subjects enrolled in the study will be placed on the study medication.
干预措施: low calorie diet (Other)
结局指标
主要结局
Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)
时间窗: 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.
次要结局
- Percent Weight Change(Pre-operatively and 3 months post-operatively)
- Body Mass Index(3 months post-operatively)
- Percent Body Fat(3 months post-operatively)
- Resting Metabolic Rate(3 months post-operatively)