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NCT Number: NCT02208141

Leipzig Adipose Tissue Childhood Cohort

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.

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Key information

Conditions

Childhood Obesity Body Weight Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Pediatric Research Leipzig (CPL)

Leipzig, Saxony, 04103, Germany

Location status: Recruiting

Location contact

Antje Körner, Prof. Dr.

CONTACT

[email protected]

0049/(0)341-9726854

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adipose tissue dysfunction

    Time frame: 10 years

    Adipose tissue dysfunction is assessed by evaluation of adipocyte size and number (hypertrophy vs. hyperplasia), adipocyte proliferation and differentiation, (lipid) cellular metabolism, inflammation, gene expression, fibrosis, and others; the association of AT dysfunction with clincial phenotype will be assessed

Secondary outcomes

  1. Presence of brown adipose tissue (BAT)

    Time frame: 10 years

    Adipose tissue samples will be evaluated for the presence of BAT on histological and molecular level and association with clinical phenotype will be investigated

  2. Inflammation of adipose tissue

    Time frame: 10 years

    Inflammation will be assessed by evaluating macrophage infiltration on histological and molecular expression level. Also, association with clinical phenotype will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Antje Körner, Prof. Dr.

CONTACT

[email protected]

0049/(0)341-9726854

Robert Stein, MD

CONTACT

[email protected]

0049/(0)341-9726537

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Determinants of Adipose Tissue Development and Obesity in Children and Adolescents

Important dates

Study start
2010
Primary completion
2030
Study completion
2030
First posted
Aug 4, 2014
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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