NCT01794650已完成不适用
The Metabolic and Glycaemic Responses to Changes in the Glycaemic Index of the Meal Consumed After Performing Evening Exercise in Type 1 Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 24 hour blood glucose area under the curve
研究概览
简要总结
The investigators hypothesise that manipulating the glycaemic index of the meal after exercise and before sleep will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-50 years old (male or female).
- •Free from any diabetes related complications (apart from mild background diabetic retinopathy).
- •HbA1c <8.5%.
- •Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
- •Demonstrate normal cardiac function in response to exercise.
排除标准
- •Aged younger than 18, or older than 50 years.
- •Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
- •HbA1c >8.5%.
- •Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
- •Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
结局指标
主要结局
24 hour blood glucose area under the curve
时间窗: 24 hours
24 hour, post-exercise, glucose area under the curve.
次要结局
- Ketogenesis(60 minutes before and 24 hours post-exercise)
研究者
研究点 (2)
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