Treatment of Low Metabolic Rate Following Bariatric Surgery
This study has been completed.
Information provided by (Responsible Party):
Oregon Weight Loss Surgery, LLC
First received: May 8, 2012
Last updated: September 22, 2015
Last verified: September 2015
Purpose is to determine the effect of ephedrine and caffeine, on metabolic rate and weight loss after bariatric surgery. Approximately 40% of patients struggle with their weight loss rate, or metabolic rate, after bariatric surgery, and at least 30% previously had or develop a low metabolic rate after surgery. Metabolic rate is the speed at which calories are burned. The fewer the calories eaten and the more calories burned, the more rapidly weight is lost. It is possible that despite a very low calorie intake following bariatric surgery metabolic rate will decrease so much so that weight does not decrease even if intake is reduced to 1000 calories per day. Ephedrine is a medicine used commonly to treat asthma, difficulty breathing, and wheezing. However, 40 years ago it was reported in scientific studies that ephedrine increases weight loss in patients on low calorie diets by increase the amount of calories that are burned. Combining caffeine with ephedrine makes ephedrine work more efficiently (more weight loss over time). Many studies show the effect of ephedrine on weight loss that began in 1974 with patients on food diets. Ephedrine used in various strengths and with a number of different combinations has shown to be effective and safe, especially when directed by a physician. There is only one study where ephedrine has been used in patients after bariatric surgery. In that study, both the patient and medical staff knew they were taking ephedrine (i.e., they were not "blinded"). The patients who were not losing weight or had measured low metabolic rates were treated with ephedrine. The patients taking ephedrine lost more weight after surgery than those not taking ephedrine. While this is a significant finding, the study was not designed to be the best test of the effects of ephedrine. The best test is where neither the patients nor the medical staff know if the patient is taking the active drug (double blind). All patients enrolled into the Research Study will receive capsules that contain either ephedrine and caffeine (the active drug) or identical capsules with no active ingredient (called a "placebo"). Neither group of patients will know which set of capsules they receive. The expected duration of treatment in the Study is 7 months from the day of surgery. This is a single site study. All patients will have their gastric bypass performed through Oregon Weight Loss Surgery at Legacy Good Samaritan Hospital. The investigators expect to study 200 patients with 100 receiving the study drugs (ephedrine and caffeine in a capsule) and 100 receiving placebo (inactive ingredients in an identical capsule) over approximately 6 months.
Drug: Ephedrine sulfate with caffeine
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||Treatment of Low Metabolic Rate and Low Weight Loss Rate Following Bariatric Surgery
Primary Outcome Measures:
- Change in Resting Energy Expenditure from baseline [ Time Frame: 3 and 6 months after treatment begins ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Body Impedance Analysis will be measured at each office visit before and after beginning treatment using a Quantum III BIA from RJL Systems (Michigan)
Secondary Outcome Measures:
- Change in Body Mass Index from baseline [ Time Frame: 8, 14, 20, 26, 32 weeks after treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Heart rate will be determined at two time points in each arm at each office visit.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Qualify for gastric bypass or sleeve gastrectomy (fertile females with negative pregnancy test)
- Willing to comply with scheduled follow up appointments
- Blood pressure < 140/80 and heart rate < 100 measured three times
- Treated hypertension with blood pressure still > 140/80
- Stroke or myocardial infarction within the last 12 months
- Angina currently requiring medical treatment
- On medication or a device to control arrhythmias
- On a beta blocker to treat hypertension
- On medications known to interact with ephedrine or caffeine
- Unable to tolerate side effects
- Fertile females unwilling to practice effective birth control
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596907
|Oregon Weight Loss Surgery, LLC
|Beaverton, Oregon, United States, 97210 |
|Oregon Weight Loss Surgery
|Portland, Oregon, United States, 97210 |
Oregon Weight Loss Surgery, LLC
||William J Raum, MD PhD
||Oregon Weight Loss Surgery
||Oregon Weight Loss Surgery, LLC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 8, 2012
||September 22, 2015
||United States: Food and Drug Administration
Keywords provided by Oregon Weight Loss Surgery, LLC:
resting energy expenditure
fat free mass
lean body mass
Low metabolic rate
Low lean body mass
Weight loss rate
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 24, 2016
Signs and Symptoms
Central Nervous System Stimulants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Purinergic P1 Receptor Antagonists
Respiratory System Agents