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

University of Leipzig

Status: Completed

Conditions: Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT01605123

KFO152/SFB1052-C5

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 6 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

Lean children

Description:

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;

Obese children

Description:

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 Exercise Group

Description:

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.

Classical Lifestyle Intervention

Description:

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.