NCT01282060Unknown不适用
Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients
Association Pour la Recherche en Diabetologie et en Geriatrie0 个研究点目标入组 986 人开始时间: 2009年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 986
- 主要终点
- Link between HbA1c level and the overall mortality rate at 5 years.
研究概览
简要总结
The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.
详细描述
The GERODIAB study is the first prospective, longitudinal follow-up cohort study, the main aim of which is to assess the link between glycaemic balance (evaluated on the basis of HbA1c levels) and total mortality at 5 years in diabetic patients aged 70 and over, and suffering from type 2 diabetes. An extension to 10 years is considered given the innovative features of this cohort follow-up procedure.
The secondary endpoints are as follows:
- To assess the link between glycaemic balance and the mortality rate with specific causes.
- To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications.
- To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy.
- To specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with type 2 diabetes, aged 70 and over,
- •Patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years),
- •Diabetes diagnosed for at least one year,
- •Patient with autonomy defined by a score greater than or equal to 3/6 on the ADL scale,
- •Patient who can be monitored during hospital or private consultations over the next 10 years,
- •Patient who did not refuse to take part in the study after receiving information on the study (Patient Information Leaflet), Patients are monitored in the hospital or private sector throughout France.
排除标准
- •Patient with type 1 diabetes,
- •Patient with secondary diabetes (mainly corticosteroid-induced),
- •Patient with a loss of autonomy defined by a score of less than 3/6 on the ADL scale,
- •Patient who cannot be monitored in the months or years to come,
- •Patient in an acute situation (transient exclusion criterion),
- •Patient expressing their refusal to participate in the study.
结局指标
主要结局
Link between HbA1c level and the overall mortality rate at 5 years.
时间窗: 5 years
The primary endpoint is to assess the link between glycaemic balance (assessed on the basis of the HbA1c level) and the overall mortality rate at 5 years for patients of 70 and over suffering from type 2 diabetes.
次要结局
- Link between HbA1c level and the onset of or changes in cognitive disorders.(5 years)
- Role of other cardiovascular risk factors(5 years)
- Link between HbA1c level and the onset of or changes in diabetes-related complications(5 years)
- Link between HbA1c level and specific causes of death.(5 years)
- Link between HbA1c level and nutritional status.(5 years)
- Link between HbA1c level and loss of autonomy.(5 years)
研究者
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