Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13,049
- 主要终点
- number of familial hypercholesterolemia or pre-type-1-diabetes
研究概览
简要总结
This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.
详细描述
The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary blood sample and the screening questionnaire will be done by the registered pediatricians in their local medical practices.
After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center.
In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials.
All data will be registered in a study database.
Follow-up pre-type 1 diabetes:
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children living in Lower Saxony (primary residence)
- •Age between 2 and 6 years (both included)
- •Written consent by at least one parent / legal representative
- •Willingness to deliver 200 µl of capillary blood
- •Willingness to complete a questionnaire
- •Willingness to participate to the follow-up visits
排除标准
- 未提供
结局指标
主要结局
number of familial hypercholesterolemia or pre-type-1-diabetes
时间窗: 18 month
identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes
次要结局
未报告次要终点
研究者
Olga Kordonouri
Prof. Dr.
Kinderkrankenhaus auf der Bult