Overview

Condition obesity
Sponsor University of Leipzig
Collaborator German Research Foundation
Start date April 2007
End date January 2020
Trial size 200 participants
Trial identifier NCT01605123, KFO152/SFB1052-C5

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.

Recruiting in the following locations…

United States No locations recruiting
Other countries Germany

Study Design

Observational model case-control
Time perspective prospective
Arm
n=100 (anticipated), n=70 currently Age: 6-25 years BMI-SDS: -1.88 to +1.23 , currently -0.25±0.77; Height-SDS: > - 2 SDS, currently 0.03±1.07;
n=106 Age: 6-25 years BMI-SDS: >1.23 , currently 2.41±0.52; Height-SDS: > - 2 SDS, currently 0.80±1.18;
Obese children will engage in increased physical activity (one to two lessons per week) at 40-60 and 60-80% of maximal exercise capacity (n=50 each anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes.
Obese children will receive a classical lifestyle intervention, including dietary, activity and psychosocial counselling (n=50 anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes.

Primary Outcomes

Measure
cardiovascular dysfunction
time frame: 7 years

Eligibility Criteria

All participants from 6 years up to 25 years old.

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

Additional Information

Official title Leipzig Artherobesity Childhood Cohort
Principal investigator Antje Körner, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by University of Leipzig.