NCT00223574已完成不适用
Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 10
- 主要终点
- glycated hemoglobin
研究概览
简要总结
A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate, low glycemic index diet, results in more rapid progression of diabetes; i.e. increased fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate, low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves glycemic control and beta-cell function
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
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or non-pregnant/non-lactating females with type 2 diabetes treated by diet alone
- •age 53-75y
- •body mass index 25-40kg/m^2 (Caucasian) or 23-40kg/m^2 (other)
- •HbA1c <=130% of upper limit of normal of local hospital lab
排除标准
- •use of any hypoglycemic or anti-hyperglycemic drug within 6 months of randomization
- •major cardiovascular event or major surgery within 6 months of randomization
- •serum triglycerides >10mmol/L
- •presence of other major debilitating disorder such as liver disease, renal failure or cancer
- •presence of gastrointestinal disorder or use of drug which is likely to alter gastrointestinal motility or nutrient absorption
- •use of oral steroids
- •substance or alcohol abuse
- •simultaneous participation in another clinical trial
- •allergy or intolerance to more than one of wheat, barley, corn, oats, potato, legumes, nuts, psyllium, olives, avocado or canola
- •unwilling or unable to follow the protocol and/or give informed consent
- •subjects planning to be on holiday for more than 8 weeks in a row or a total of 12 weeks in the year in locations to which they will not take study food
结局指标
主要结局
glycated hemoglobin
次要结局
- Body weight
- waist circumference
- occurrence of diet failure
- fasting glucose
- fasting C-reactive protein
- fasting lipids (total, HDL and LDL cholesterol and triglcyerides)
- fasting apolipoproteins A1 and B100
- fasting free fatty acids
- fasting short chain fatty acids
- plasma glucose and insulin 30, 60 and 120min after 75g oral glucose
- insulin sensitivity (HOMA)
- beta-cell function (30min-fasting insulin)/(30min-fasting glucose)
- metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile)
- quality of life
- gastrointestinal symptoms
- diet satisfactio
研究者
研究点 (10)
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