Treatment of Low Metabolic Rate Following Bariatric Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Oregon Weight Loss Surgery, LLC
Sponsor:
Information provided by (Responsible Party):
Oregon Weight Loss Surgery, LLC
ClinicalTrials.gov Identifier:
NCT01596907
First received: May 8, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Intervention
Morbid Obesity
Drug: Ephedrine sulfate with caffeine
Drug: cellulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Low Metabolic Rate and Low Weight Loss Rate Following Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Oregon Weight Loss Surgery, LLC:

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.


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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

Contacts
Contact: William J Raum, MD PhD 503-227-5050 wraum@oregonweightlosssurgery.com
Contact: Jamie Laut, MA 503-227-5050 jlaut@oregonweightlosssurgery.com

Locations
United States, Oregon
Oregon Weight Loss Surgery, LLC Recruiting
Beaverton, Oregon, United States, 97210
Contact: William J Raum, MD PhD    503-227-5050    wraum@oregonweightlosssurgery.com   
Contact: Jamie Laut, MA    503-227-5050    jlaut@oregonweightlosssurgery.com   
Principal Investigator: William J Raum, MD PhD         
Sub-Investigator: Emma J Patterson, MD         
Oregon Weight Loss Surgery Recruiting
Portland, Oregon, United States, 97210
Contact: William J Raum, MD PhD    503-227-5050    wraum@oregonweightlosssurgery.com   
Principal Investigator: William J Raum, MD PhD         
Sub-Investigator: Emma J Patterson, MD         
Sponsors and Collaborators
Oregon Weight Loss Surgery, LLC
Investigators
Principal Investigator: William J Raum, MD PhD Oregon Weight Loss Surgery
  More Information

No publications provided

Responsible Party: Oregon Weight Loss Surgery, LLC
ClinicalTrials.gov Identifier: NCT01596907     History of Changes
Other Study ID Numbers: 115183
Study First Received: May 8, 2012
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Caffeine
Ephedrine
Pseudoephedrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Bronchodilator Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on August 27, 2014