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. Identifier: NCT01596907
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : September 24, 2015
Information provided by (Responsible Party):
Oregon Weight Loss Surgery, LLC

Brief 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.

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Ephedrine and caffiene

Drug treatment:

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.
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

Primary Outcome Measures :
  1. 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

  2. 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)

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pregnancy
  • Fertile females unwilling to practice effective birth control

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Oregon Weight Loss Surgery, LLC
Principal Investigator: William J Raum, MD PhD Oregon Weight Loss Surgery

Responsible Party: Oregon Weight Loss Surgery, LLC Identifier: NCT01596907     History of Changes
Other Study ID Numbers: 115183
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Oregon Weight Loss Surgery, LLC:
resting energy expenditure
fat free mass
lean body mass
bariatric surgery
morbid obesity
Low metabolic rate
Low lean body mass
Weight loss rate

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants