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NCT01596907 · ClinicalTrials.gov registry record · NA
Treatment of Low Metabolic Rate Following Bariatric Surgery
A NA study of Morbid Obesity, sponsored by Oregon Weight Loss Surgery.
- Completed
- Registry status
- NA
- Development phase
- 218
- Enrollment target
- 2
- Study locations
NCT01596907: Completed NA study of Morbid Obesity, sponsored by Oregon Weight Loss Surgery.
NCT01596907 is a NA study of Morbid Obesity that has completed, run by Oregon Weight Loss Surgery. The registered enrollment target is 218 participants, above the 113-participant average among 24 other Morbid Obesity trials with a reported enrollment target (93% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596907, a NA study of Morbid Obesity, has completed, sponsored by Oregon Weight Loss Surgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 218 participants
- Enrollment target
- 2
- Study locations
Study 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
Primary Outcome
By indirect calorimetry resting energy expenditure will be calculated from vO2 and vCO2 ratios using the Harris-Benedict Equations
Conditions Studied
Interventions
- DRUG Ephedrine sulfate with caffeine
- DRUG cellulose
Study Locations (2)
Oregon
- Oregon Weight Loss Surgery, LLC - Beaverton
- Oregon Weight Loss Surgery - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-07 |
| Phase | NA |
What the finished NCT01596907 record still lists
NCT01596907 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 113-participant average among 24 other Morbid Obesity trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Morbid Obesity appearing as the primary indexed condition, and to 2 interventions - of which Ephedrine sulfate with caffeine is the first listed.
NCT01596907 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT01596907 about?
NCT01596907 is a clinical study titled "Treatment of Low Metabolic Rate Following Bariatric Surgery". 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 aft...
What is the current status of trial NCT01596907?
This trial is currently completed. It is a NA study. The enrollment target is 218 participants. The study started on 2012-05. Estimated completion is 2015-07.
What conditions does trial NCT01596907 study?
This clinical trial studies the following conditions: Morbid Obesity.
What interventions are being tested in trial NCT01596907?
The interventions under investigation include: Ephedrine sulfate with caffeine (DRUG), cellulose (DRUG).
Who is sponsoring clinical trial NCT01596907?
This trial is sponsored by Oregon Weight Loss Surgery, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01596907 being conducted?
This trial has 2 study locations across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Morbid Obesity
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Where NCT01596907's enrollment target sits among peer trials
218 4th of 24 higher than 21 of 24 other Morbid Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Morbid Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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