Two Pieces of Fruit to Type 2 Diabetics?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Hba1c
研究概览
简要总结
It has been questioned whether patients with type 2 diabetes who are advised to restrict their fruit consumption to two or less pieces of fruits daily have better outcomes (HbA1c, body weight, fruit intake and serum lipids) after three months compared to patients with type 2 diabetes who are advised to eat at least two pieces of fruits.
To the investigators' knowledge, no randomized controlled trial has evaluated this.
The investigators therefore perform a randomized controlled trial including 76 patients with type 2 diabetes to investigate this.
The investigators' hypothesis is that:
Type 2 diabetics who are advised to restrict their fruit consumption have the same Hba1c three months after an initially dietary treatment as type 2 diabetics who are advised not to restrict their fruit consumption.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients refered from a general practitioner
排除标准
- •no Hba1c when refered
- •Hba1c lower than 5% or higher than 12%
- •patients that require a translator
- •patients with severe cardiovascular, renal or endocrine disease
- •psychiatric patients
- •pregnant patients
结局指标
主要结局
Change in Hba1c
时间窗: three months
次要结局
- change in bodyweight(three months)
- change in serum lipids(three months)
- change in fruit intake(three months)
研究者
Allan Stubbe Christensen
MHSc, RD
Hospitalsenheden Vest