Qsymia as an Adjunct to Surgical Therapy in the Superobese
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02301416|
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Metabolic Surgery Weight Loss Bariatric Surgery Procedures||Drug: Phentermine/topiramate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Qsymia as an Adjunct to Surgical Therapy in the Superobese|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||June 27, 2018|
|Actual Study Completion Date :||June 27, 2018|
All subjects enrolled in the study will be placed on the study medication.
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 Name: Qsymia
- Roux en Y Gastric Bypass [ Time Frame: 24 months post-operatively ]Proportion of patients to meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia.
- Percent weight loss [ Time Frame: Pre-operatively and 24 months post-operatively ]Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
- Percent body fat [ Time Frame: Pre-operatively and 24 months post-operatively ]Change in percent body fat both before and after surgery.
- Resting Metabolic Rate [ Time Frame: pre-operatively and 24 months post-operatively ]Change in resting metabolic rate during the pre-operative period and 24 months post-operatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301416
|United States, North Carolina|
|Wake Forest Baptist Health|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Jamy D Ard, MD||Wake Forest University Health Sciences|