Treatment of Low Metabolic Rate Following Bariatric Surgery
|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: NCT01596907|
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : September 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Drug: Ephedrine sulfate with caffeine Drug: cellulose||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Treatment of Low Metabolic Rate and Low Weight Loss Rate Following Bariatric Surgery|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Active Comparator: Ephedrine and caffiene
ephedrine sulfate 25-mg with caffeine 200-mg per capsule to be given three times per day 4 hours apart for 6 months after gastric bypass surgery. Weight loss rate, resting energy expenditure, fat free mass will be measured during the treatment.
Drug: Ephedrine sulfate with caffeine
Ephedrine sulfate 25-mg with caffeine 200-mg combination capsule to start 5 weeks after gastric bypass surgery at 3 times per day 4 hours apart.
Placebo Comparator: placebo
one placebo capsule will be taken three times per day 4 hours apart, identical to the instructions for the active drug for approximately 6 months following gastric bypass surgery. Weight loss rate, resting energy expenditure and fat free mass will be measured during the treatment.
sufficient cellulose to fill a placebo capsule identical to the active drug to be taken 3 times per day 4 hours apart for 6 months after gastric bypass surgery
- Change in Resting Energy Expenditure from baseline [ Time Frame: 3 and 6 months after treatment begins ]By indirect calorimetry resting energy expenditure will be calculated from vO2 and vCO2 ratios using the Harris-Benedict Equations
- Change in Body Composition from baseline [ Time Frame: 3 months and 6 months after beginning treatment ]Body Impedance Analysis will be measured at each office visit before and after beginning treatment using a Quantum III BIA from RJL Systems (Michigan)
- Change in Body Mass Index from baseline [ Time Frame: 8, 14, 20, 26, 32 weeks after treatment ]Body Mass Index will be calculated from weight and height obtained at each office visit.
- Arterial Blood Pressure [ Time Frame: 8, 14, 20, 26, 32 weeks after treatment ]Arterial blood pressure will be obtain in both arms times two at each office visit.
- Heart Rate [ Time Frame: 8, 14, 20, 26, 32 weeks after treatment ]Heart rate will be determined at two time points in each arm at each office visit.
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): NCT01596907
|United States, Oregon|
|Oregon Weight Loss Surgery, LLC|
|Beaverton, Oregon, United States, 97210|
|Oregon Weight Loss Surgery|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||William J Raum, MD PhD||Oregon Weight Loss Surgery|