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Recruiting NCT02208141

Leipzig Adipose Tissue Childhood Cohort

Observational Childhood Obesity Insulin Resistance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Childhood Obesity, Insulin Resistance. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Determinants of Adipose Tissue Development and Obesity in Children and Adolescents

Overview

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.

Primary outcome measures

  • Adipose tissue dysfunction [Time frame: 10 years]
Secondary outcome measures (2)
  • Presence of brown adipose tissue (BAT) [Time frame: 10 years]
  • Inflammation of adipose tissue [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Center for Pediatric Research Leipzig (CPL) — Leipzig

Publications

  • 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. PMID 36384443
  • 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. PMID 27748745

Identifiers

NCT: NCT02208141 · IFB ADI K7-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗