Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Weight Loss in the elderly african american population
研究概览
简要总结
The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy on clinical outcomes for persons with diabetes. The primary outcomes of this studies include A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of disease progression and management as well as costs of medical care provided throughout the intervention period.
详细描述
Data collected as a result of this project will be evaluated in aggregate to demonstrate the potential impacts on health and medical costs available through this type of intervention, with long-term goals of reducing disability and deaths due to chronic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African-American subjects
- •Males or females 65 - 85 years of age
- •Body mass index (BMI) equal to or greater than 30 kg/m2
- •Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
- •Ability to understand and be willing to adhere to the study protocol
- •A known history of type 2 diabetes mellitus greater than 3 months, receiving either diet alone or oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
排除标准
- •Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.
- •Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.
- •Mental condition rendering the subject unable to understand the scope of the study.
结局指标
主要结局
Weight Loss in the elderly african american population
时间窗: 6 months to 1 year
次要结局
- Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity(6 months to 1 year)
研究者
Guillermo Umpierrez
Professor
Emory University