Short Term Diet Intervention in Newly Diagnosed Type 2 Diabetes. a Randomised, Multicentric, Controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- whole body insulin sensitivity
研究概览
简要总结
Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2 diabetes.
This study aims to explore the effect of diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.
详细描述
This study is a randomised, multicenter controlled trial Our Aim is to test the effects of an 8-week diet lacking red meat, containing increased fibers and coffee (verum) versus standard recommendation (control)in a multicenter setting.
We are expecting that the verum diet will improve insulin sensitivity and insulin secretion due to reductions in visceral and hepatic fat along with improved adipocyte cytokine secretion profiles
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients
- •disease duration for five years or less,
- •age of 69 years or less,
- •body mass index of 30 kg/m2 or more,
- •hemoglobin A1c of 5,5 % to 9%
- •patient should be on standard diet or metformin +/- acarbose monotherapy
- •patient should be without
排除标准
- •for coffee consumption
- •Exclusion Criteria:
- •disease duration more than five years,
- •age of > 69 years,
- •body mass index of < 30 kg/m2,
- •hemoglobin A1c < 5,5 % or > 9%
- •if patient becomes insulin therapy
- •if patient has exclusion criteria for coffee consumption
- •if patient is non-compliant with study protocol
- •if patient is pregnant
- •if patient has acute infection
- •if patient has anaemia
- •if patient has malignancies
- •if patient has autoimmune or immune compromising diseases including HIV/AIDS
- •if patient has psychiatric diseases or addiction
结局指标
主要结局
whole body insulin sensitivity
时间窗: 8 weeks
measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
次要结局
- intramyocellular lipids(8 weeks)
- skeletal muscle mitochondrial function - phosphate-recovery time(8 weeks)
- hepatocellular lipids(8 weeks)
- insulin secretion(8 weeks)
- total body fat(8 weeks)
- skeletal muscle mitochondrial function - insulin signaling(8 weeks)
- pancreatic fat(8 weeks)