The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- Relative change in Blood sugar
研究概览
简要总结
A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may not be ideal for patients with diabetes. This concern is particularly pertinent to the breakfast meal, which often contains mainly CHO. Clinical observations suggested that such diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital "no concentrated sweets (NCS)" breakfast meals with more balanced meals. The study team hypothesized that a balanced breakfast would improve pre-lunch BG values.
This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD). Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All patients on Ward A (with and without diabetes) were given the intervention breakfast for the first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS meals). After 4 weeks, the standard and intervention wards were switched. Data were collected only on patients with diabetes who were able to consume meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adults with cardiovascular disease who were admitted to 2 pre-specified wards at Duke Medical Center during the study period
- •Diagnosis of diabetes (type 1 or 2) or newly identified hyperglycemia (blood glucose of >200 on 2 separate occasions)
- •Able to consume food by mouth
排除标准
- •Intensive care patients
- •No intake by mouth (enteral, parenteral, NPO)
- •Taking in nutrition supplements (Ensure, etc)
结局指标
主要结局
Relative change in Blood sugar
时间窗: Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.
The primary outcome will be the relative change between the pre-breakfast and pre-lunch blood glucose levels after the intervention breakfast. The hypothesis is that the intervention breakfast will lead to lower pre-lunch blood sugars. Blood glucoses will be measured before breakfast and lunch on eligible patients. This will occur every day for the duration of the study (8 weeks). The relative change between the pre-breakfast and pre-lunch blood glucose will be assessed by BG2 (pre-lunch) minus BG1 (pre-breakfast).
次要结局
未报告次要终点