Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- change in insulin secretion (glucagon stimulation test)
研究概览
简要总结
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
详细描述
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects
- •18-79 years old
- •type 2 diabetes
排除标准
- •renal insufficiency
- •immunosuppression
- •previous symptomatic cancer diagnosis
- •acute cardiovascular disease (stroke, coronary syndrome)
- •pregnancy and lactation
- •severe psychiatric disorders
- •corticoid or other immunosuppressive therapy
研究组 & 干预措施
low-carb diet, followed by conventional DGE diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)
干预措施: dietary consulting and advise (Behavioral)
very-low calory diet, followed by conventional diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines
干预措施: dietary consulting and advise (Behavioral)
结局指标
主要结局
change in insulin secretion (glucagon stimulation test)
时间窗: 3 weeks, 1 year
change in insulin secretion (glucagon stimulation test)
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
时间窗: 3 weeks, 1 year
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
change in hepatic fat content (MR-S)
时间窗: 3 weeks, 1 year
change in hepatic fat content (MR-S)
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
时间窗: 3 weeks, 1 year
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
时间窗: 3 weeks, 1 year
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
次要结局
- change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)(3 weeks, 1 year)
- inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)(3 weeks, 1 year)
- change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds(3 weeks, 1 year)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Director of the Department for Clinical Nutrition
German Institute of Human Nutrition