The Effect of a 2-week vs. 6-week Low-calorie Diet (LCD) Followed by Roux-en-Y Gastric Bypass (RYGB) on Body Composition and Surgery Outcomes in Obese Humans: a Dietary Intervention and Magnetic Resonance Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet
研究概览
简要总结
Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat content and size thereby improving surgical outcomes. This study aims to investigate whether a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI). The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further than the conventional food pre-operative diet.
详细描述
The morbidly obese subjects (BMI higher then 40 kg/m2) were randomised and assessed at baseline (week 0). After 2 weeks on a low-calorie diet (LCD), participants underwent either Roux-en-Y gastric bypass (RYGB) or continued with a LCD for 4 weeks.The participants will reassess at week 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing Roux-en-Y gastric bypass at Imperial Weight Centre
- •aged 18 to 60 years
- •boby mass index of 35 to 55 kg/m2
排除标准
- •Claustrophobia
- •Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging
- •Current pregnancy or breast feeding for females (as determined by a pregnancy test)
- •A full term pregnancy within the last year for females
- •Treatment with any medication that might affect the study outcomes
- •Haemorrhagic disorders and anticoagulant treatment
- •History of cancer, excluding skin cancer
- •History of severe or multiple allergies, severe adverse drug reaction or leucopenia
- •Regular drinkers of more than three units of alcohol daily
- •History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit
- •Regular intake of over-the-counter (OTC) medication (other than the occasional paracetamol/aspirin)
- •Poor compliers or subjects unlikely to commit to the 26 week study duration
- •Blood donation within the 12 week period before the initial study dose
- •Use of monoamine oxidase inhibitors (MAOIs) as anti depressant
研究组 & 干预措施
2-week LCD and Roux-en-Y gastric bypass (RYGB)
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
干预措施: Liquid formula low-calorie diet (LCD) (Dietary Supplement)
2-week LCD and Roux-en-Y gastric bypass (RYGB)
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
干预措施: Roux-en-Y gastric bypass (RYGB) (Procedure)
6-week LCD
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
干预措施: Liquid formula low-calorie diet (LCD) (Dietary Supplement)
Control diet
1000 calorie diet
干预措施: Roux-en-Y gastric bypass (RYGB) (Procedure)
Control diet
1000 calorie diet
干预措施: Control diet (Other)
结局指标
主要结局
Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet
时间窗: at 2 weeks or 6 weeks depending on group
Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy
次要结局
- Operative Time(at the time of surgery)
- Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass(at 6 months following Roux-en-Y gastric bypass)
- Complexity of Surgery(at the time of surgery)
- Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass(at 1-month following Roux-en-Y gastric bypass)