Clinical trial NCT02208141: Leipzig Adipose Tissue Childhood Cohort
Official title: Determinants of Adipose Tissue Development and Obesity in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Obesity
Insulin Resistance
Keywords: children
obesity
adipose tissue dysfunction
inflammation
macrophage infiltration
insulin resistance
dyslipidemia
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children and adolescents undergoing surgery at the University Hospital Leipzig

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adipose tissue dysfunction
timeFrame: 10 years
Secondary outcomes:
measure: Presence of brown adipose tissue (BAT)
timeFrame: 10 years
measure: Inflammation of adipose tissue
timeFrame: 10 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Center for Pediatric Research Leipzig (CPL)
state: Sachsen
Study officials:
affiliation: University of Leipzig
name: Antje Körner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.