Clinical Characteristics of People With Long-term Type 1 Diabetes: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- the development or progression of diabetic retinopathy
研究概览
简要总结
Type 1 diabetes (T1D) is characterized by absolute insulin deficiency. Although the discovery and application of exogenous insulin has prolonged the lifespan of T1D patients, the chronic diabetic complications caused by long-term poor glycemic control will still reduce patients' quality of life and the overall life expectancy. According to the studies focused on long-term T1D, part of the patients with long disease duration showed resistance to microvascular complications, and several protective factors have been identified. The prevalence of T1D in China is extremely low compared to that in the western world, and little is known about the characteristics of patients with long-term T1D in China. Therefore, this study is designed to collect variable clinical and laboratory features of patients with long-term T1D, explore the risk and protective factors for the development of microvascular complications, and provide reference for the prediction and prevention of these complications.
详细描述
This is a single-center, prospective, observational study. The investigators propose to enroll 400 patients with type 1 diabetes (T1D) ≥10 years. The patients will be followed up annually for 3 years.
In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two people is inconsistent, the auxiliary staff decides which data to use.
Missing data will be filled in with the multiple imputation method. The regression analysis will be used to explore the risk and protective factors for the development and progression of microvascular complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with type 1 diabetes(T1D) according to the 1999 World Health Organization report
- •Insulin dependence from disease onset
- •with T1D duration of ≥10 years
- •able to understand the procedures and methods of this study, voluntarily participate in the study, and agree to sign the informed consent form
排除标准
- •patients with type 2 diabetes, gestational diabetes, or specific types of diabetes
- •patients with mental disability or have any other condition or disease that may hamper compliance with the protocol
结局指标
主要结局
the development or progression of diabetic retinopathy
时间窗: from May 2022 to December 2025
diagnosed by an ophthalmologist based on fundus photography
the development or progression of diabetic nephropathy
时间窗: from May 2022 to December 2025
measured by urine microalbumin/creatinine
次要结局
- the changes of memory function(from May 2022 to December 2025)
- the changes of bone mineral density(BMD)(from May 2022 to December 2025)
- the changes of brachial-ankle pulse wave velocity(baPWV)(from May 2022 to December 2025)
- the changes of language function(from May 2022 to December 2025)
- the changes of executive function(from May 2022 to December 2025)
- the changes on magnetic resonance imaging(MRI)(from May 2022 to December 2025)
- the changes of carotid intima-media thickness(IMT)(from May 2022 to December 2025)
研究者
Xia Li
Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, Nationa Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
Second Xiangya Hospital of Central South University