Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany

NCT ID: NCT02750527

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13049 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed Description

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:

During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes.

Follow-up familial hypercholesterolemia:

During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.

Conditions

Type 1 Diabetes; Familial Hypercholesterolemia

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• none

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kinderkrankenhaus auf der Bult

OTHER

Sponsor Role: lead

Responsible Party

Olga Kordonouri

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Kordonouri, MD

Role: PRINCIPAL_INVESTIGATOR

Kinder- und Jugendkrankenhaus AUF DER BULT

Other Identifiers

H-Fr1dolin-01

Identifier Type: -

Identifier Source: org_study_id