Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children

The investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age.

To identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally after 5, 7 and 9 years.

In addition, the investigators will assess the effects of increased physical activity and exercise on cardiovascular function.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig, Leipzig, Saxony, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

height -2 to +2 SDS
pubertal stage adequate for age
no medications
written consent of guardians and children≥12y
weight ≥ -2 SDS

Exclusion criteria

secondary/syndromal obesity
known existing hypertension
chronic disease (eg. errors of metabolism)
acute illness (eg. respiratory tract infection)
previous hypertensive or antidiabetic treatment- weight loss attempts 6 weeks prior to assessment

Treatment and study plan

Primary outcomes

cardiovascular dysfunction

Time frame: 7 years

Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

German Research Foundation

Registry information

Official study title

Leipzig Artherobesity Childhood Cohort

Important dates

Study start: 2007
Primary completion: 2017
Study completion: 2017
First posted: May 24, 2012
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.

Published trials that share one or more normalized conditions with this study.

Completed