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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Heidelberg University.
Recruitment status was:  Recruiting
Information provided by:
Heidelberg University Identifier:
First received: February 22, 2007
Last updated: May 8, 2007
Last verified: March 2007
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
Behavioral: low fat and polysaccharide rich diet
Behavioral: specific physical training program for obese children

Study Type: Interventional
Study Design: Allocation: Randomized
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.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00439933

Contact: Joerg Tafel, Dr +4962215638606
Contact: Peter P Nawroth, Prof +496221568601

University Hospital Heidelberg, Department of Internal Medicine I Recruiting
Heidelberg, Germany, 69120
Contact: Joerg Tafel, MD    +49-6221-5638606   
Principal Investigator: Jörg Tafel, MD         
Sponsors and Collaborators
Heidelberg University
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 Identifier: NCT00439933     History of Changes
Other Study ID Numbers: 1-Tafel
Study First Received: February 22, 2007
Last Updated: May 8, 2007

Keywords provided by Heidelberg University:
Weight loss
Endothelial dysfunction

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms processed this record on May 25, 2017