Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin (A1C) changes
研究概览
简要总结
This is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes.
Study terminated December 19, 2005 for administrative reasons.
详细描述
Traditional dietary treatment of type 2 diabetes is complicated and often fails.
This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals.
A series of 10 overweight type 2 diabetic patients not well controlled, or needing medication for control, will be recruited to follow this plan; followup is to be until 6 months after the last patient is enrolled, or when all patients have normal A1Cs with no medication, whichever comes first.
Primary endpoints to be measured are A1C, weight loss (in pounds and BMI reduction) and medication reduction. Secondary endpoints are occurrences of hypoglycemia, reduction of medications for hypertension and hyperlipidemia, and patient satisfaction. As this is a Phase 1 trial, the only control group is historical controls (the patients themselves and the medical literature).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus, type 2
- •Ability to attend office visits in Manassas, Virginia
排除标准
- •Institutionalized living
- •Retinopathy, neuropathy
- •Pregnancy
- •Serious health problems such as heart disease or stroke
结局指标
主要结局
Glycated hemoglobin (A1C) changes
Weight (body mass index [BMI]) loss
Diabetes medication reduction
次要结局
- Hypoglycemia
- Patient satisfaction
- Other medication reduction