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

Leipzig Artherobesity Childhood Cohort

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01605123
Enrollment
200
Registered
2012-05-24
Start date
2007-04-30
Completion date
2017-12-31
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

endothelial function, children, obesity, cardiovascular dysfunction, carotid intima media thickness, blood pressure, oral glucose tolerance test

Brief summary

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.

Interventions

None listed

Sponsors

German Research Foundation
CollaboratorOTHER
University of Leipzig
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
cardiovascular dysfunction7 yearsAssessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026