Polyneuropathy in Diabetes Mellitus Type 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 490
- 试验地点
- 2
- 主要终点
- Presence of diabetic polyneuropathy
研究概览
简要总结
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).
Perspective: The study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.
详细描述
Diabetic polyneuropathy is one of the most common long-term complications of diabetes. Neuronal hyperexcitability is thought to be a key factor in the development of neuropathic pain.
The overall purpose of this study is to evaluate the prevalence and underlying mechanisms of diabetic polyneuropathy and painful diabetic polyneuropathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Pregnancy
- •Poor or no Danish language skills
- •Insufficient mental capacity to provide informed consent or complete questionnaires
- •Additional criteria for healthy controls:
- •Any neurological or psychiatric disorder
- •Chronic pain
- •Severe illness
- •Pain treatment 3 days before the examination
结局指标
主要结局
Presence of diabetic polyneuropathy
时间窗: 5 hours
For case definition of neuropathy, Tesfaye et al. 2010 will be used.
Presence of painful diabetic polyneuropathy
时间窗: 5 hours
Neuropathic pain grading system. Finnerup et al. 2016 will be used.
次要结局
未报告次要终点