Office of Human Research, Taipei Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- HbA1c After Intervention
研究概览
简要总结
In order to response the increasing of aging population cause losing ability that need long-care needs, the project entitled "10-year long-term care program" from Executive Yuan in 2007 is carried out to assist economically disadvantaged and disabled elderly to acquire daily nutrition. Therefore, the long-term care resident's nutritional status got more attention than before. Out of control in blood glucose will not only increase bed sores and urinary tract infection in tube feeding residents but also rise medical expenditures. The nutritional status of long-term care institutions, anyang homes and nursing home are generally bad in nutrition management due to high cost of nutritional supplements from foreign imports that cause the burden of families. In this study, we will recruit diabetic subjects that divide into white sweet potato group (experimental group) and commercial formula group (control group) by using randomized, parallel and open clinical study through tube feeding in sixty days.
详细描述
All subjects will be evaluated the blood sugar and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long-term stability nasogastric or gastrostomy-fed person.
- •The physician diagnosed as diabetic and regular use of hypoglycemic drugs.
排除标准
- •Psychosis or depression.
- •Hba1c> 8.5%.
- •High taking nutritional supplements or steroids drugs.
- •Have undergone abdominal surgery caused by intestinal sticky.
- •Suffering from cancer, ulcers, respiratory infections and other diseases.
- •Currently receiving central venous nutrition therapy or intravenous nutrition therapy.
- •Liver dysfunction (ALT ≧ 100 U / L), renal insufficiency (creatinine ≧ 3mg / dl), heart failure (NYFc II above), moderate anemia (hemoglobin <9 g / dl).
研究组 & 干预措施
Control Group
Commercial diabetic formula
干预措施: Commercial diabetic formula (Dietary Supplement)
Treatment Group
White sweet potato formula
干预措施: White sweet potato formula (Dietary Supplement)
结局指标
主要结局
HbA1c After Intervention
时间窗: 60 days
HbA1c value after 60 days intervention in both groups
次要结局
- Albumin After Intervention(60 days)
- Glucose After Intervention(60 days)
- Total Cholesterol After Intervention(60 days)
- Triglyceride After Intervention(60 days)