Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)
研究概览
简要总结
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.
The aim of this study is to asses the influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.
详细描述
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.
The aim of this study is to asses influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.
Clinical remission was defined as time in which all of the following criteria were met: HbA1c below 6.5 % , dose of exogenous insulin below 0.3 U / kg body weight and serum C-peptide concentration above 0.5 ng / ml. Patients were divided into those who were in remission at any time during follow-up (remitters) and non-remitters.
At follow-up occurrence of chronic microvascular complications of diabetes (retinopathy, diabetic kidney disease and neuropathy) was evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria.
- •Age 18-35 years
- •Education with regard to intensive functional insulin therapy at the time of diagnosis
- •Patient consent to participation in the study
排除标准
- •Acute inflammation (serum C-reactive protein concentration (hsCRP) >10mg/L, leukocytosis >15x109/L, erythrocyte sedimentation rate (OB) >30 mm/h)
- •Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range
- •History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)
- •Other autoimmunological diseases other than diabetes
- •Not confirming type 1 diabetes after obtaining results of autoantibodies
结局指标
主要结局
Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)
时间窗: Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.
次要结局
未报告次要终点
研究者
Paweł Niedźwiecki
MD Paweł Niedźwiecki
Poznan University of Medical Sciences