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Trial record 50 of 153 for:    "familial hypercholesterolemia"

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

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ClinicalTrials.gov Identifier: NCT02750527
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Olga Kordonouri, Kinderkrankenhaus auf der Bult

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.

Condition or disease
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
Estimated Enrollment : 150000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Study Start Date : September 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2028





Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750527


Sponsors and Collaborators
Kinderkrankenhaus auf der Bult
Investigators
Principal Investigator: Olga Kordonouri, MD Kinder- und Jugendkrankenhaus AUF DER BULT

Responsible Party: Olga Kordonouri, Prof. Dr., Kinderkrankenhaus auf der Bult
ClinicalTrials.gov Identifier: NCT02750527     History of Changes
Other Study ID Numbers: H-Fr1dolin-01
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypercholesterolemia
Hyperlipoproteinemia Type II
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias