Life Without Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Changes in insulin sensitivity
研究概览
简要总结
The aim of the study 'Live - without diabetes' is to investigate the effects of increased physical activity on a daily basis with or without (high intense interval training) HIIT (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes
详细描述
A total of 125 individuals with pre-diabetes will be included and randomized into four different groups (N=25, each group): 1) Increased daily activity detected by the pedometer, 2) increased daily activity detected by the pedometer + HIIT, 3) HIIT, and 4) increased daily activity detected by the pedometer + group intervention 5) a control group (maintain unchanged activity and life-style during the duration of the study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Body mass index (BMI) > 25 kg/m2
- •Prediabetes: 6.1 % ≤ glycated hemoglobin A1c (HbA1c) ≤ 6.4 % and / or increased fasting plasma glucose (FPG): 6.1 mM ≤ FPG ≤ 6.9 mM and / or abnormal glucose tolerance (7.8 mM ≤ 2 hour plasma glucose (PG) ≤ 11.0 mmol)
- •Weekly training status <150 minutes
排除标准
- •BMI <25 kg/m2
- •Pregnancy and breastfeeding
- •Treatment with medicine, there influence glucose metabolism
- •Decreased liver function (liver transaminases > 3 times of limit of normal)
结局指标
主要结局
Changes in insulin sensitivity
时间窗: At baseline and after 12 weeks
The primary endpoint is insulin sensitivity, and it will be assessed by changes in the area under the curve from baseline to end-of-study assessed by the Cederholm Index and Matsuda Index
次要结局
- Patient-reported outcome measure(At baseline and after 12 weeks)
- Changes in key proteins in glucose and fat metabolism (Adipose fat tissure)(At baseline and after 12 weeks)
- Changes in key proteins in glucose and fat metabolism (Skeletal muscle)(At baseline and after 12 weeks)
- Changes in body weight (kg)(At baseline and after 12 weeks)
- Changes in oxygen peak oxygen uptake(At baseline and after 12 weeks)
- Changes in glycaemic control(At baseline and after 12 weeks)
研究者
Pernille Mensberg
MSc, ph.d-student
University Hospital, Gentofte, Copenhagen