Comparison of a High-protein, Carbohydrate-restricted Diet With a High Proportion of Leguminous Protein Compared to Animal Protein on Metabolic Control in Patients With Type 2 Diabetes, "LeguAN Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Variance of glucose metabolism after different diet intervention
研究概览
简要总结
This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism.
详细描述
2x20 patients with Diabetes mellitus type 2 are randomise by a blind computer assist for an equal allocation in both groups (animal protein vs. plant protein). The food components for both groups are 40% carbohydrates, 30% fat and 30% protein. The carbohydrates are correspond with a high fiber content and a low blood sugar effectiveness of carbohydrates (glycemic index).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus, type 2
- •HbA1c between 6-11%
排除标准
- •Consumptive or high grade diseases
- •Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
- •Diabetes type 1
- •Pregnancy
- •Chronic disease of heart, kidney, liver
- •High grade anaemia
- •High grade infection disease
- •Relevant change of body weight (+/- 5 kg) since 8 weeks before begin of study Intervention
- •Missing data about primary outcome measures (hyperinsulinaemic euglycaemic clamp, mealtime test, data about dietary intake from food diaries or food protocols)
- •Significant deviation from dietary targets during the monitored 6 weeks isoenergetic period
- •Allergies including food allergies
结局指标
主要结局
Variance of glucose metabolism after different diet intervention
时间窗: week 0 and 6
Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT)
次要结局
- Development of indices for the prediction of liver fat mass(week 0 and 6)
- Development of indices for the prediction of body fat mass(week 0, 2, 4 and 6)
- Expression Change of inflammatory markers in blood and fat tissue(week 0 and 6)
- Modification of epigenetic DNA(week 0 and 6)
- Changes of gastrointestinal microbiota(week 0 and 6)
- Variance of composite biometric data(week 0, 2, 4 and 6)
- Variance of blood data(week 0, 2, 4 and 6)
- Variance of intestinal hormones(week o and 6)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Director/Dep. Clinical Nutrition
German Institute of Human Nutrition