Skip to main content
Clinical Trials/NCT01605123
NCT01605123
Completed
Not Applicable

Leipzig Artherobesity Childhood Cohort

University of Leipzig2 sites in 1 country200 target enrollmentApril 2007
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Leipzig
Enrollment
200
Locations
2
Primary Endpoint
cardiovascular dysfunction
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
December 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Leipzig
Responsible Party
Principal Investigator
Principal Investigator

Antje Koerner, Prof. Dr. med.

Prof. Dr. med.

University of Leipzig

Eligibility Criteria

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

Outcomes

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

Study Sites (2)

Loading locations...

Similar Trials