Treatment of Low Metabolic Rate Following Bariatric Surgery
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
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.