Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 12409 for:    LIFE Child
Previous Study | Return to List | Next Study

LIFE Leipzig Research Centre for Civilization Diseases (LIFE-Child)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02550236
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
European Social Fund
European Regional Development Fund
State of Saxony
Information provided by (Responsible Party):
Antje Koerner, Prof. Dr. med., University of Leipzig

Brief Summary:

The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective longitudinal population-based study with a life course approach to health and disease.

The LIFE Child Study focuses on two main research objectives:

  • What are premises of normal growth, development and health in children?
  • Which factors contribute to the development of non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems?

Detailed assessments will be conducted alongside long-term storage of biological samples in 2,000 pregnant women and more than 10,000 children and their families.


Condition or disease
Childhood Obesity

Detailed Description:
  • The LIFE Child study is part of LIFE, a life sciences research program of the University of Leipzig (Leipzig Research Centre for Civilization Diseases - LIFE). The measurements are performed in a well-equipped research centre located on the premises of the University Hospital of Leipzig.
  • The study collects detailed information from clinical examinations, questionnaires and interviews and includes a collection of several types of biological materials at various time points (urine, hair, blood for direct analyses, genomic DNA, dried blood spots, paxgenes (for RNA isolation and expression/eQTL studies). Children and adolescents from 0-18 years at baseline and their families are included. Participants will be followed annually over a period of ten years irrespective of the age at the first participation in the study.
  • Prenatal examinations are conducted in the 24th and 36th week of gestation and postnatal examinations in 3., 6. and 12. month in the offspring. The birth cohort study collects detailed information from clinical examinations, questionnaires and interviews and biological materials (blood, cord blood, placental tissue, breast milk, hair, urine)
  • In addition, the LIFE Child study focuses in certain disease cohorts and disease free controls in more detail. The aim of these subgroups is to examine aetiological associations and comorbidities with more in-depth methods. There are two disease cohorts: LIFE Child OBESITY, LIFE Child DEPRESSION.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Population-based Childhood Cohort Study in the Leipzig Area Investigating Genetic, Environmental, and Metabolic Factors and Their Association With the Development of Civilization Diseases
Study Start Date : October 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort
LIFE Child Health
The LIFE Child HEALTH cohort is a sample of 10.000 children and adolescents. A basic program that will be carried out annually at each study centre visit. This program includes clinical history (perinatal and past medical history, medications, allergies, immunizations, developmental history and family history) clinical examination, collection of blood, hair and urine samples, anthropometry and different age-dependent questionnaires. Questionnaires are completed by the parents and starting at the age of eight years also by the child itself.
LIFE Child Obesity
The LIFE Child OBESITY cohort is a sample of 1,500 obese children and adolescents that will be assessed and compared to a lean control group (N=1,500) with equally detailed phenotyping including metabolic and cardiovascular evaluation. The LIFE Child OBESITY cohort (including the control group) performs the basic program of the LIFE Child HEALTH cohort plus additional parameters such as electrical bioimpedance, assessment of basal metabolic rate, oral glucose tolerance test, spiroergometry and measurement of endothelial function using EndoPAT.
LIFE Child Health: Pregnancy/Birth
The LIFE child Pregnancy/Birth cohort is a sample of 2,000 pregnant women and their offspring. Prenatal examinations are conducted during the 24th to 26th and 34th to 36th week of gestation. During the first year of life, data is collected from children at 3, 6 and 12 month of age.



Primary Outcome Measures :
  1. Civilization diseases and their risk factors [ Time Frame: 10 years ]
    Assess lifestyle, metabolic and genetic risk factors of civilization diseases (e.g. diabetes mellitus, obesity, allergy, cardiovascular diseases) from fetal life to adulthood.


Biospecimen Retention:   Samples With DNA
  • blood samples for mRNA and DNA analysis
  • serum samples
  • plasma samples
  • serum samples from oral glucose tolerance testing
  • urine samples
  • hair samples
  • mother's milk


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The LIFE Child study is a prospective longitudinal population-based cohort study. All children with their families and pregnant women of the area of Leipzig are eligible to participate in the LIFE Child study. This sample is supposed to represent the population of the city.
Criteria

Inclusion Criteria:

  • children with their families and pregnant women of the area of Leipzig

Exclusion Criteria:

  • severe diseases

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): NCT02550236


Contacts
Layout table for location contacts
Contact: Wieland Kiess, Prof., MD wieland.kiess@medizin.uni-leipzig.de
Contact: LIFE Child contact@life.uni-leipzig.de

Locations
Layout table for location information
Germany
LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Wieland Kiess, Prof. MD       wieland.kiess@medizin.uni-leipzig.de   
Contact: LIFE Child       contact@life.uni-leipzig.de   
Principal Investigator: Wieland Kiess, Prof., MD         
Principal Investigator: Antje Körner, Prof.,MD         
Sponsors and Collaborators
University of Leipzig
European Social Fund
European Regional Development Fund
State of Saxony
Investigators
Layout table for investigator information
Principal Investigator: Wieland Kiess, Prof., MD University of Leipzig
Principal Investigator: Antje Körner, Prof., MD University of Leipzig

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Antje Koerner, Prof. Dr. med., Prof. Dr. med. Antje Körner, University of Leipzig
ClinicalTrials.gov Identifier: NCT02550236    
Other Study ID Numbers: LIFE Child Leipzig
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antje Koerner, Prof. Dr. med., University of Leipzig:
Children
Obesity
Pregnancy
Growth
Lifestyle
Metabolic and cardiovascular health
Birth
Development
Additional relevant MeSH terms:
Layout table for MeSH terms
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms