Leipzig Adipose Tissue Childhood Cohort

Insulin Resistance Clinical Trial

Official title:

Determinants of Adipose Tissue Development and Obesity in Children and Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02208141
• Other study ID #: IFB ADI K7-10
• Status: Recruiting
• Start date: October 2010
• Est. completion date: December 2030

Study information

• Verified date: November 2023
• Source: University of Leipzig
• Contact: Antje Körner, Prof. Dr.
• Phone: 0049/(0)341-9726854
• Email: Antje.Koerner[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Insulin Resistance
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
Germany	Center for Pediatric Research Leipzig (CPL)	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adipose tissue dysfunction	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	10 years
Secondary	Presence of brown adipose tissue (BAT)	Adipose tissue samples will be evaluated for the presence of BAT on histological and molecular level and association with clinical phenotype will be investigated	10 years
Secondary	Inflammation of adipose tissue	Inflammation will be assessed by evaluating macrophage infiltration on histological and molecular expression level. Also, association with clinical phenotype will be assessed.	10 years

External Links

•   Link to "Integrated Research and Treatment Center (IFB) Adiposity Diseases, Leipzig"
•   Link to Prof. Dr. med. Antje Körner's research group: "childhood obesity"
•   Link to University Children's Hospital Leipzig