Poznan Prospective Study of Type 1 Diabetic Patients Treated With Intensive Insulin Therapy From the Onset of the Disease.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 主要终点
- Neuropathy
研究概览
简要总结
The purpose of this study is to evaluate the development and progression of chronic complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular events) in patients with type 1 diabetes treated from the onset of the disease with recommended method of intensive insulin therapy. All patients attended a five-day structured training program during first hospitalization and re-education once year during the observation. After five years of observation and next - once a year chronic complications are assessed. The investigators would like to evaluate also the relationship of the management of the disease, knowledge about the treatment and diabetes, insulin resistance and inflammatory markers with development and progression of chronic complications.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 1 diabetes mellitus with features of complete insulin deficiency (serum C-peptide level <0.05 ng/ml, acetonuria, blood gases disturbances such as: pH <7.30, BE< -6 mmol/l, HCO3 <18 mmol/l)
- •Age < 35 years old
- •Educational course in intensive insulin therapy started at the onset of the disease after treatment of ketoacidosis
- •Written consent
排除标准
- •Uncertain type of diabetes mellitus
- •Kidney failure (serum creatinine level > 1.1 mg/dl)
- •Liver dysfunction (AspAt > 31 U/l, AlAt > 34 U/l)
- •Acute inflammatory process
- •Other concomitant diseases (i.e. neoplasm)
结局指标
主要结局
Neuropathy
时间窗: 1 year
Retinopathy
时间窗: 1 year
Cardiovascular events
时间窗: 1 year
stroke, heart infarct, death
Diabetic chronic renal disease
时间窗: 1 year
次要结局
- Intima media thickness(1 year)
- Metabolic management of diabetes(1 year)
- Quality of life(1 year)
研究者
Aleksandra Uruska
Prof. Dorota Zozulinska -Ziolkiewicz
Poznan University of Medical Sciences