Metabolic Effects of a Low Carbohydrate Versus Energy-matched Standard Diet in Morbidly Obese Individuals With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in intrahepatic triglyceride content
研究概览
简要总结
To investigate the metabolic effects of a low carbohydrate versus energy-matched standard diet in morbidly obese individuals with prediabetes awaiting bariatric surgery.
详细描述
The metabolic benefits of calorie restriction in obese people with or without impaired glycaemia are well-established. The impact of diet composition, however, remains poorly understood. Hepatic lipid content strongly correlates with hepatic insulin resistance, which is a key feature of the pre-diabetic state. The investigators hypothesize that a low carbohydrate diet compared to an energy-matched standard diet in morbidly obese patients with prediabetes scheduled for bariatric surgery results in greater reduction in liver fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male subjects aged 18 years or older
- •BMI >35 kg/m2 awaiting bariatric surgery
- •Pre-diabetes according to American Diabetes Association criteria (HbA1c 5.7%-6.4%)
- •Capacity to give informed consent and adhere to study procedures
排除标准
- •Excess alcohol consumption (> 3 units/day for men, > 2 units/day for women)
- •Moderate to severe kidney disease
- •Nephrolithiasis
- •Pregnancy/breastfeeding
- •Current participation in another clinical trial
- •Claustrophobia
- •MRI-contraindications (pacemaker/defibrillator, neurostimulator, drug pump, cochlear implant, heart valve/vascular clips, shunt valve)
结局指标
主要结局
Change from baseline in intrahepatic triglyceride content
时间窗: 2 weeks
The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy
次要结局
- Change from baseline in liver size(2 weeks)
- Change from baseline in whole body fat mass(2 weeks)
- Change from baseline in body weight(2 weeks)
- Change from baseline in insulin secretion(2 weeks)
- Change from baseline in visceral adipose tissue(2 weeks)
- Change from baseline in insulin sensitivity(2 weeks)