Treatment of Low Metabolic Rate and Low Weight Loss Rate Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Change in Resting Energy Expenditure from baseline
研究概览
简要总结
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.
详细描述
Research Objectives:
The primary objective is to apply an effective medical weight loss treatment to post bariatric surgery patients to enhance their weight loss through stimulation of thermogenesis and lipolysis and retention of lean body mass. This treatment using ephedrine with phosphodiesterase inhibitor (caffeine or theophylline) has been extensively documented as safe and effective in the medical weight loss setting but has not been applied to post-bariatric surgery patients in a placebo controlled, double blind, randomized study. From preliminary studies this treatment should be effective, especially in the treatment of post-surgical patients who continue to have difficulty losing weight despite good activity levels and significant calorie restriction.
Clinical Relevance:
Raum and others have been treating patients presenting with low metabolic rates during medical and bariatric surgery induced weight loss for many years with ephedrine in combination with caffeine and/or theophylline. All the literature outlined below for the last 40 years have been conducted only during medical weight loss. There are no randomized trials in surgical patients. Abstracts and expert opinion papers have been published but without randomization or blinding.
Ephedrine has become controversial despite considerable evidence of its safe and effective treatment of airway resistance (asthma) for 50 years, and its use for medical weight loss (to stimulate REE and prevent loss of lean body mass) since 1974. An association with a non-regulated food additive, ephedra sparked the initial problems with inappropriate dosing, lack of physician supervision for patient selection and sensationalism in the lay press unsupported by peer-reviewed studies to contradict previous favorable studies. Secondly, using ephedrine and pseudoephedrine as substrate for the illegal manufacture of methamphetamine, caused an aura of further unreasoned apprehension. Because ephedrine with caffeine or theophylline is one of the few drug combinations that can potentially reverse a low REE and allow a successful weight loss following bariatric surgery, a randomized, controlled study is needed to determine if this effect is statistically and clinically significant in patients having bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ephedrine sulfate with caffeine (Drug)
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.
干预措施: cellulose (Drug)
结局指标
主要结局
Change in Resting Energy Expenditure from baseline
时间窗: 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
Change in Body Composition from baseline
时间窗: 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)
次要结局
- 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)