Treatment of Low Metabolic Rate Following Bariatric Surgery

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.

Conditions

• Morbid Obesity

Interventions

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.

DRUG

cellulose

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

Sponsors & Collaborators

• Oregon Weight Loss Surgery, LLC

  lead OTHER

Principal Investigators

• William J Raum, MD PhD · Oregon Weight Loss Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• United States

Study Locations