NCT00544206已完成2 期
Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- mean glucose level
研究概览
简要总结
To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed and dated informed consent
- •diagnosis of type 2 diabetes
- •HbA1c between 7.0 and 9.0%
- •18 - 75 years of age
- •currently receiving a standard enteral product
- •anticipated duration on tube feeding at least one month
- •100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
- •anticipated life expectancy is more than or equal to 6 months
- •free of infections
- •no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose
排除标准
- •composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
- •composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
- •significant cardiovascular event less than or equal to 2 weeks prior to study entry
- •major surgery less than or equal to 2 weeks prior to study entry
- •pre-planned surgery during the study period
- •active malignancy, including melanoma and excluding cutaneous malignancies
- •severe dementia
- •known allergies to medical grade adhesives and/or skin disinfectants
- •taking octreotide
- •chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
- •participation in a concomitant trial
研究组 & 干预措施
#1
Experimental
Diabetes specific enteral feeding product
干预措施: Diabetes specific feeding product (Other)
#2
Active Comparator
Standard enteral feeding product
干预措施: standard enteral feeding product (Other)
结局指标
主要结局
mean glucose level
时间窗: 24 hours
次要结局
- fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin(24 hours)
研究者
研究点 (1)
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