Comparison of Two Protocols on the Implementation of a Fasting Day to Check the Basal Insulin Replacement in Type 1 Diabetes: Complete Fasting Compared to the Permission for Carbohydrate- and Calorie-free Food
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma glucose day- and night profiles
研究概览
简要总结
This is a prospective study with a "crossover design", where fasting with a day of complete fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods are compared in a randomized order. Underlying hypothesis is that at the same basal insulin substitution with the fasting of both protocols , no significant differences in the glucose-day or -night profiles revealed. So the same conclusions regarding the "consistency" of basal insulin dosing revealed during the implementation of the part of patients is rated as more pleasant when calories and carbohydrates-free food are allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Basal insulin substitution with neutrales Protamin Hagedorn (NPH) -insulin (at least twice a day), insulin detemir (twice a day), insulin glargine (once or twice a day) or with insulin pump
- •Diabetes duration > 2 years
- •Body-mass-index between 19 and 35 kg/m², including
- •written consent
排除标准
- •No pregnancy in woman
研究组 & 干预措施
Fasting day without any food
Complete fasting: On a fast day under this Protocol no solid food may be eaten unless it is solid, medically prescribed part of a bedtime snack just before falling asleep (which must sometimes be to prevent nocturnal hypoglycaemia with injection of basal insulin before going to sleep) , Otherwise, the patient have ad libitum access to mineral water and unsweetened tea (possibly a fluid intake restriction should be considered for other diseases).
干预措施: Fasting day (Other)
Fasting day with calorie- & carbohydrate-free food
During a fasting day for this protocol, patients may calories in unlimited quantity and (with calorie-free dressing) Take carb food like tomatoes, cucumbers, lettuce to be, both during meal periods and in between, if desired.
干预措施: Fasting day (Other)
结局指标
主要结局
Plasma glucose day- and night profiles
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Michael A. Nauck
Prof. Dr. med. Michael A. Nauck
Diabeteszentrum Bad Lauterberg im Harz