NCT01055093招募中不适用
Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
German Diabetes Center1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2005年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change of insulin sensitivity (M-Value)
研究概览
简要总结
The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex distribution.
详细描述
In detail, the following questions will be answered:
- Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis?
- Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)?
- Can we identify subgroups at baseline with different progression of the disease? Patients are thoroughly examined at baseline and after 2, 5, and 10 years with annual telephone contacts in between.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of diabetes mellitus according to ADA criteria
- •Age 18-69
- •Diabetes duration since diagnosis < 12 months
- •Control cohort: proven normal glucose tolerance according to ADA criteria
排除标准
- •Diabetes mellitus category 3 B-H (ADA criteria)
- •Pregnancy
- •Severe renal, liver or heart disease
- •malignant cancer
- •severe psychiatric illness or addiction
- •participation in an intervention trial
结局指标
主要结局
Change of insulin sensitivity (M-Value)
时间窗: 2 and 5 years
measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
次要结局
- Incidence of any diabetic complication(2-10 years)
- Change of insulin secretion(2 and 5 years)
研究者
研究点 (1)
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