Leipzig Adipose Tissue Childhood Cohort

Recruiting

• Conditions: Childhood Obesity; Insulin Resistance

• Registration Number: NCT02208141
• Lead Sponsor: University of 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adipose tissue dysfunction	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 Outcome Measures

Name	Time	Method
Presence of brown adipose tissue (BAT)	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
Inflammation of adipose tissue	10 years	Inflammation will be assessed by evaluating macrophage infiltration on histological and molecular expression level. Also, association with clinical phenotype will be assessed.

Trial Locations

Locations (1)

Center for Pediatric Research Leipzig (CPL); 🇩🇪 Leipzig, Sachsen, Germany