POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism 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 hepatic fat content (MR-S)
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. This core comparison is dealt with in the DiNA-D study (published elsewhere).
POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.
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 and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).
POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.
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
结局指标
主要结局
change in hepatic fat content (MR-S)
时间窗: 49 weeks
change in hepatic fat content (MR-S)
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
时间窗: 49 weeks
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: 49 weeks
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
change in insulin secretion (glucagon stimulation test)
时间窗: 49 weeks
change in insulin secretion (glucagon stimulation test)
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
时间窗: 49 weeks
change in blood glucose profile 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)(49 weeks)
- inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)(49 weeks)
- change in parameters of peripheral neuropathy - pain thresholds(49 weeks)
- change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)(49 weeks)
- change in parameters of peripheral neuropathy - vibration threshold(49 weeks)
- change in parameters of peripheral neuropathy - thermal sensitivity(49 weeks)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
PI
German Institute of Human Nutrition