Leipzig Adipose Tissue Childhood Cohort

NCT ID: NCT02208141

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study the investigators hypothesize that pathological alterations in adipose tissue biology already occur during the development and progression of obesity in children and adolescents. The investigators aim to identify and characterize mechanisms and molecular targets that affect the development of adipose tissue and ensuing obesity in childhood and adolescence.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators aim to identify how adipose tissue dysfunction in childhood contributes to the development of obesity and related comorbidities and to characterize factors that play a role in the development of adipose dysfunction in children. The investigators will employ a translational approach which is based on the characterization of adipose tissue biology in samples of children to determine alterations leading to adipose tissue dysfunction. These include assessment of the composition (including BAT), remodeling, function, metabolism and inflammation of adipose tissue as well as the adipokine profile. For the assessment of clinical relevance, these experimental data will then be correlated with the clinical phenotype. Finally, we aim to identify factors responsible for early adipose tissue dysfunction and characterize them for their clinical and functional relevance.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

lean and obese children and adolescents

study cohort may be stratified for lean (definded as BMI \<1.28 SDS) and overweight/obese (definded as BMI\>= 1.28 SDS) children for posthoc analyses no intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* body weight: 3000 g - 180 kg
* suitable surgical procedure
* signed informed consent by the guardians and the study participant, if older 12 years

Exclusion Criteria

* severe chronic and inflammatory diseases
* acute or chronic infections
* oncological diseases
* clotting disorders
* complications during surgical procedure
* drug treatment
* nil by mouth
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Antje Koerner, Prof. Dr. med.

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antje Körner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Pediatric Research Leipzig (CPL)

Leipzig, Saxony, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Antje Körner, Prof. Dr.

Role: CONTACT

0049/(0)341-9726854

Robert Stein, MD

Role: CONTACT

0049/(0)341-9726537

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Antje Körner, Prof. Dr.

Role: primary

0049/(0)341-9726854

References

Explore related publications, articles, or registry entries linked to this study.

Kempf E, Landgraf K, Vogel T, Spielau U, Stein R, Raschpichler M, Kratzsch J, Kiess W, Stanik J, Korner A. Associations of GHR, IGF-1 and IGFBP-3 expression in adipose tissue cells with obesity-related alterations in corresponding circulating levels and adipose tissue function in children. Adipocyte. 2022 Dec;11(1):630-642. doi: 10.1080/21623945.2022.2148886.

Reference Type DERIVED
PMID: 36384443 (View on PubMed)

Loffler D, Landgraf K, Rockstroh D, Schwartze JT, Dunzendorfer H, Kiess W, Korner A. METRNL decreases during adipogenesis and inhibits adipocyte differentiation leading to adipocyte hypertrophy in humans. Int J Obes (Lond). 2017 Jan;41(1):112-119. doi: 10.1038/ijo.2016.180. Epub 2016 Oct 17.

Reference Type DERIVED
PMID: 27748745 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://kik.uniklinikum-leipzig.de/kikcms.site,postext,childhood-obesity-antje-koerner,a_id,1062.html

Link to Prof. Dr. med. Antje Körner's research group: "childhood obesity"

http://www.ifb-adipositas.de/en

Link to "Integrated Research and Treatment Center (IFB) Adiposity Diseases, Leipzig"

http://kik.uniklinikum-leipzig.de/

Link to University Children's Hospital Leipzig

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IFB ADI K7-10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Leptin Biology in Adipose Tissue
NCT01800864 COMPLETED NA
Weight Gain and Adipose Tissue
NCT02703766 COMPLETED NA