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Clinical Trials/NCT02750527
NCT02750527
Completed
Not Applicable

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

Kinderkrankenhaus auf der Bult0 sites13,049 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Kinderkrankenhaus auf der Bult
Enrollment
13049
Primary Endpoint
number of familial hypercholesterolemia or pre-type-1-diabetes
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
December 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kinderkrankenhaus auf der Bult
Responsible Party
Principal Investigator
Principal Investigator

Olga Kordonouri

Prof. Dr.

Kinderkrankenhaus auf der Bult

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

  • Not provided

Outcomes

Primary Outcomes

number of familial hypercholesterolemia or pre-type-1-diabetes

Time Frame: 18 month

identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes

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