Weight Loss in Obese Children and Adolescents and Its Effect on Improvement of Destructive Changes in Blood Vessels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00439933
First received: February 22, 2007
Last updated: May 8, 2007
Last verified: March 2007
  Purpose

Obesity in children and adolescents is associated with morphologic and functional changes of the vascular wall, suggesting a potential role of juvenile obesity for the development of atherosclerosis later in life. However, no evidence from intervention studies has been provided so far that weight loss in obese children can improve vascular function. Therefore we designed this study including a cohort of obese children before and after a structured weight reduction program in order to answer the question, whether such an intervention can improve vascular function and reverse destructive vascular changes.


Condition Intervention
Obesity
Behavioral: low fat and polysaccharide rich diet
Behavioral: specific physical training program for obese children

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Weight Loss in Obese Children and Adolescents and Its Effect on Improvement of Endothelial Dysfunction

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • changes in flow-mediated dilation of the brachial artery
  • intima media thickness of the brachial artery

Secondary Outcome Measures:
  • weight reduction

Estimated Enrollment: 180
Study Start Date: April 2007
Detailed Description:

Obesity is an epidemic disease with a rapid increase in children and adolescents. According to the National Health and Nutrition Examination Surveys, the prevalence of overweight children doubled between 1976-1980 and 1999-2002 and affected 15 percent of children and adolescents in the United States. Further investigations have shown that obese children and adolescents have a high risk for the persistence of overweight into adulthood, and that morbidity and mortality are higher in those obese adults who became overweight during childhood, compared to those whose weight-gain evolved later in life. A tremendous increase in obesity-related morbidity and furthermore an immense rise in the medical costs associated with it, is to be expected. Growing evidence suggests that obesity in childhood is not only associated with a markedly increased prevalence of prediabetes or diabetes mellitus, dyslipidemia and other cardiovascular risk factors, but also predicts the development of coronary artery disease and other atherosclerotic complications in adulthood. A 55-year follow-up study showed that overweight in adolescence lead to an increased risk of morbidity and mortality from cardiovascular events. This effect is even independent of adult weight. There is evidence, that markers of early yet reversible states of atherosclerosis, such as decreased flow-mediated dilation of the brachial artery (FMD) and increased intima media thickness (IMT), correlate with measures of body weight and are predictive of cardiovascular disease.

While several studies have demonstrated that weight loss can improve metabolic risk factors in obese children, data regarding the effect on early vascular disease is missing. Therefore we designed this study including a cohort of obese children before and after a structured weight reduction program in order to answer the question, whether such an intervention can improve endothelial cell function and reverse an increased intima media thickness. Since each intervention program leading to body weight reduction is a severe interference with personal lifestyle, we feel that these questions need to be answered before intervention programs are initiated on a public health basis.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children between 7 and 10 years with tanner 0 or 13 to 17 years with tanner 4 or 5
  • body mass index > 97th percentile

Exclusion Criteria:

  • severe medical disorders in addition to obesity
  • severe psychosocial impairments
  • known endocrine or genetic causes for obesity
  • family history of premature cardiovascular disease
  • factors affecting vascular function, including cigarette smoking
  • regular medication for other diseases including vitamin supplements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439933

Contacts
Contact: Joerg Tafel, Dr +4962215638606 Joerg_Tafel@med.uni-heidelberg.de
Contact: Peter P Nawroth, Prof +496221568601 Peter_Nawroth@med.uni-heidelberg.de

Locations
Germany
University Hospital Heidelberg, Department of Internal Medicine I Recruiting
Heidelberg, Germany, 69120
Contact: Joerg Tafel, MD    +49-6221-5638606    joerg_tafel@med.uni-heidelberg.de   
Principal Investigator: Jörg Tafel, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Joerg Tafel, Dr University Hospital Heidelberg, Department of Internal Medicine I
Study Chair: Peter P Nawroth, Prof University Hospital Heidelberg, Department of Internal Medicine I
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00439933     History of Changes
Other Study ID Numbers: 1-Tafel
Study First Received: February 22, 2007
Last Updated: May 8, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
Obesity
Children
Weight loss
Endothelial dysfunction
Intervention

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 18, 2014