NCT03766620已完成不适用
A Prospective, Observational Study, of a High Calorie, High Protein Tube Feeding With Slow Release Carbohydrates and Monounsaturated Fatty Acids (MUFA), in a Malnourished Population With Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Body Weight Change
研究概览
简要总结
This is a prospective, non-interventional, observational study. Malnourished subjects with diabetes, who are receiving a high calorie, high protein tube feeding with slow release carbohydrates and MUFA by their health care professional (HCP) per standard of care will be enrolled into the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study
- •Considered malnourished, or at risk for malnutrition
- •Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic medications and/or exogenous insulin
- •Conforms to the requirements set forth on the study product label
- •Under the care of a health care professional for malnutrition and has recently been prescribed tube feeding as a sole-source of nutrition by their health care professional
- •Free living, residing in a nursing home or admitted to the hospital and has anticipated length of hospital stay > 3 days and < 12 days
排除标准
- •Severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- •Cannot safely consume the study product, or known to be allergic or intolerant to any ingredient found in the study product
- •Renal or liver failure
- •Participates in another study that has not been approved as a concomitant study by AN
结局指标
主要结局
Body Weight Change
时间窗: Baseline to Study Exit Week 12
Measured in Kg
次要结局
- Malnutrition Universal Screening Tool (MUST)(Baseline to Study Exit Week 12)
- Subjective Global Assessment (SGA)(Baseline to Study Exit Week 12)
- Body Mass Index(Baseline to Study Exit Week 12)
- Glucose control(Baseline to Study Exit Week 12)
- Product Compliance(Baseline to Study Exit Week 12)
- Quality of life (EuroQol EQ-5D-5L)(Baseline to Study Exit Week 12)
- Albumin Levels(Baseline to Study Exit Week 12)
研究者
研究点 (8)
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