Treatment of Low Metabolic Rate Following Bariatric Surgery

NCT01596907 | Completed

• 1 other identifier: 115183
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 2

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.

Conditions

Morbid Obesity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Resting Energy Expenditure from baseline

  By indirect calorimetry resting energy expenditure will be calculated from vO2 and vCO2 ratios using the Harris-Benedict Equations

  3 and 6 months after treatment begins

• Change in Body Composition from baseline

  Body Impedance Analysis will be measured at each office visit before and after beginning treatment using a Quantum III BIA from RJL Systems (Michigan)

  3 months and 6 months after beginning treatment

Secondary Outcomes (3)

• Change in Body Mass Index from baseline

  8, 14, 20, 26, 32 weeks after treatment

• Arterial Blood Pressure

  8, 14, 20, 26, 32 weeks after treatment

• Heart Rate

  8, 14, 20, 26, 32 weeks after treatment

Study Arms (2)

Ephedrine and caffiene

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

Ephedrine sulfate with caffeine DRUG

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.

Ephedrine and caffiene

cellulose DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Weight Loss Surgery, LLC: lead

Study Sites (2)

Oregon Weight Loss Surgery, LLC

Beaverton, Oregon, 97210, United States

Location

Oregon Weight Loss Surgery

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Ephedrine; Caffeine; Cellulose

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• William J Raum, MD PhD

  Oregon Weight Loss Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 11, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (2)