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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
low fat and polysaccharide rich diet
specific physical training program for obese children
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Children, Weight loss, Endothelial dysfunction, Intervention

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Heidelberg, Department of Internal Medicine IRecruiting

Outcomes

Primary Outcome Measures

changes in flow-mediated dilation of the brachial artery
intima media thickness of the brachial artery

Secondary Outcome Measures

weight reduction

Full Information

First Posted
February 22, 2007
Last Updated
May 8, 2007
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00439933
Brief Title
Weight Loss in Obese Children and Adolescents and Its Effect on Improvement of Destructive Changes in Blood Vessels
Official Title
Weight Loss in Obese Children and Adolescents and Its Effect on Improvement of Endothelial Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Children, Weight loss, Endothelial dysfunction, Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
low fat and polysaccharide rich diet
Intervention Type
Behavioral
Intervention Name(s)
specific physical training program for obese children
Primary Outcome Measure Information:
Title
changes in flow-mediated dilation of the brachial artery
Title
intima media thickness of the brachial artery
Secondary Outcome Measure Information:
Title
weight reduction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joerg Tafel, Dr
Phone
+4962215638606
Email
Joerg_Tafel@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Peter P Nawroth, Prof
Phone
+496221568601
Email
Peter_Nawroth@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg Tafel, Dr
Organizational Affiliation
University Hospital Heidelberg, Department of Internal Medicine I
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter P Nawroth, Prof
Organizational Affiliation
University Hospital Heidelberg, Department of Internal Medicine I
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Heidelberg, Department of Internal Medicine I
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg Tafel, MD
Phone
+49-6221-5638606
Email
joerg_tafel@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Jörg Tafel, MD

12. IPD Sharing Statement

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

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