Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- metabolic improvement of type 2 diabetes
研究概览
简要总结
In animal models and retrospective studies, certain food components such as sugars and fiber have been detected as potential agents to influence development and progress of type 2 diabetes.
The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in patients with long-term type 2 diabetes and intensive insulin treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •type 2 diabetes, insulin-dependent
- •high insulin resistance
排除标准
- •accompanying disease, medication or metabolic disorder, which interact with glucose metabolism or eating behavior (e.g. renal insufficiency, major cardial insuffiency, untreated hypothyreosis, corticoid treatment, depression and other psychiatric disorders...)
研究组 & 干预措施
pure galactose
5 grams of galactose, three times a day with the main meals, duration: 4 weeks
干预措施: Dietary supplement (4 arms, 2 active, 2 placebo) (Dietary Supplement)
pure palatinose
5 grams of palatinose, three times a day with the main meals, duration: 4 weeks
干预措施: Dietary supplement (4 arms, 2 active, 2 placebo) (Dietary Supplement)
soluble non-fermentable fibers
5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks
干预措施: Dietary supplement (4 arms, 2 active, 2 placebo) (Dietary Supplement)
non-soluble non-fermentable fibers
5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks
干预措施: Dietary supplement (4 arms, 2 active, 2 placebo) (Dietary Supplement)
结局指标
主要结局
metabolic improvement of type 2 diabetes
时间窗: 4 weeks
metabolic improvement of type 2 diabetes, as to be shown via hyperinsulinemic-euglycaemic clamp, mixed-meal test and daily demand of insulin units
次要结局
未报告次要终点
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Director of the Department for Clinical Nutrition
German Institute of Human Nutrition