Treatment of Low Metabolic Rate Following Bariatric Surgery
|ClinicalTrials.gov Identifier: NCT01596907|
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : September 24, 2015
|Condition or disease||Intervention/treatment|
|Morbid Obesity||Drug: Ephedrine sulfate with caffeine Drug: cellulose|
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|
|Primary Completion Date :||July 2015|
|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.
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|