NCT00939679已完成不适用
ERGEM: Effect of Roux-en-Y Gastric Bypass Surgery on Energy Metabolism.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Change in 24 hour energy expenditure
研究概览
简要总结
The purpose of this study is to investigate the short term and long term effects of Roux-en-Y gastric bypass (RYGB) surgery on energy expenditure, gastrointestinal and appetite regulating hormone levels, and appetite sensation. We hypothesize that following RYGB surgery, metabolism will be elevated in comparison to patients who have not yet had RYGB but who are losing weight simultaneously using a low calorie diet. We further hypothesize that this higher metabolism will be associated with alterations in fasting and postmeal levels of gastrointestinal and appetite regulating hormones. Long term (1.5 years after RYGB), we hypothesize that differences in metabolism, body composition, and hormone levels will distinguish between patients who have maintained their weight loss after RYGB vs those who have regained weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •BMI ≥40, or ≥35 with concomitant obstructive sleep apnea, or hypertension
- •scheduled for RYGB surgery at Hvidovre Hospital, Copenhagen, Denmark
- •Must have lost between 1-4% body weight after 3 months of dietary counselling
排除标准
- •Deemed ineligible for RYGB surgery by patient's own physician(s)
- •Diabetes Mellitus
- •Non Caucasian
- •Weight >160kg (due to DEXA scanner limitations), or morphologically unable to accommodate in DEXA scanner (>40cm in maximum supine anterior-posterior dimension, or >60cm in maximum supine body width)
- •Hemoglobin <7.0 mmol/L
- •Psychiatric illness under the care of a psychiatrist
- •Eating disorder such as bulimia
- •Patients on special diets (eg vegetarian, Atkins)
- •Any history of thyroid dysfunction, or use of thyroid medication (with the exception of transient thyroiditis)
- •Hypothalamic or genetic etiology of obesity
- •A current diagnosis of cancer
- •Any surgery other than RYGB planned in the ensuing 3 months
- •Substance abuse or smoking
- •Use of prescription medications or over-the-counter drugs affecting metabolism
- •Excessive intake of alcohol (>7 drinks/week)
- •Excessive intake of caffeine (>300 mg/day)
- •Presence of any contraindication to use of a low calorie powder diet, including:
- •Past history of ventricular arrhythmias (even if treated)
- •Renal dysfunction (creatinine clearance <60 mL/min)
- •Liver enzymes (ALT or AST) >3x upper limit of normal
- •Milk protein allergy, or lactose intolerance
- •Porphyria or phenylketonuria
- •History of gout
- •Breastfeeding
- •Concomitant use of monoamine oxidase inhibitors or non potassium sparing diuretics
- •Inability or unwillingness to comply with a low calorie diet protocol
- •Patients who find the powder diet products to be unpalatable
- •Do not enjoy yogurt, carrots, or milk (as these are essential elements of the low calorie diet)
结局指标
主要结局
Change in 24 hour energy expenditure
时间窗: 7 weeks, 10 weeks (short term); 1.5 years (long term)
次要结局
- change in fasting bile acids and lipid profile(7 weeks, 10 weeks (short term); 1.5 years (long term))
- changes in fasting levels of leptin, adiponectin, and visfatin(7 weeks, 10 weeks (short term); 1.5 years (long term))
- change in body composition(7 weeks, 10 weeks (short term); 1.5 years (long term))
- Change in appetite sensation(7 weeks, 10 weeks (short term); 1.5 years (long term))
- change in fasting and postprandial levels of GLP-1, PYY, oxyntomodulin, glucose, insulin, C peptide, GIP, ghrelin, cholecystokinin(7 weeks, 10 weeks (short term); 1.5 years (long term))
研究者
AAstrup
Head of Department
University of Copenhagen
研究点 (4)
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