Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany (Fr1dolin)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Familial Hypercholesterolemia

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.

• Study Type: Observational
• Enrollment (Actual): 13049

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

According to the Federal Statistical Office (31.12.2014) 320.000 children in the age of 2 to 6 years are living in lower Saxony, Germany. Based on the Fr1da experience a participation rate of 25-35 % is expected. The current estimated prevalence of FH und T1D of 1:300 leads to the expected number of 450 newly identified cases of FH and T1D in each case in the period of 18 months. Additional subjects with FH would be identified by cascade screening.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of familial hypercholesterolemia or pre-type-1-diabetes	identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes	18 month

Collaborators and Investigators

• Sponsor: Kinderkrankenhaus auf der Bult
• Investigators: Principal Investigator: Olga Kordonouri, MD, Kinder- und Jugendkrankenhaus Auf der Bult

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypercholesterolemia; Hyperlipoproteinemia Type II
• Other Study ID Numbers: H-Fr1dolin-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No