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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

German Research Foundation

Information provided by (Responsible Party):

Prof. Dr. Antje Koerner, University of Leipzig

ClinicalTrials.gov Identifier:

NCT01605123

First received: May 22, 2012

Last updated: May 23, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 22, 2012

Last Updated Date

May 23, 2012

Start Date ^ICMJE

April 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

cardiovascular dysfunction [ Time Frame: 7 years ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01605123 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Leipzig Artherobesity Childhood Cohort

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Serum samples, samples from oral glucose tolerance tests, EDTA/DNA samples, primary cells (endothelial progenitor cells), peripheral blood mononuclear cells), urine

Sampling Method

Non-Probability Sample

Study Population

Obese children from our out-patient department in Leipzig, Germany Lean children community-based from Leipzig

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Lean children
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
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
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
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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 25 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01605123

Other Study ID Numbers ^ICMJE

KFO152/SFB1052-C5

Has Data Monitoring Committee

Responsible Party

Prof. Dr. Antje Koerner, University of Leipzig

Study Sponsor ^ICMJE

University of Leipzig

Collaborators ^ICMJE

German Research Foundation

Investigators ^ICMJE

Principal Investigator:

Antje Körner, MD

University of Leipzig

Information Provided By

University of Leipzig

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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