NCT00439933

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
Last Updated

May 9, 2007

Status Verified

March 1, 2007

First QC Date

February 22, 2007

Last Update Submit

May 8, 2007

Conditions

Obesity

Keywords

ObesityChildrenWeight lossEndothelial dysfunctionIntervention

Outcome Measures

Primary Outcomes (2)

  • changes in flow-mediated dilation of the brachial artery

  • intima media thickness of the brachial artery

Secondary Outcomes (1)

  • weight reduction

Interventions

low fat and polysaccharide rich dietBEHAVIORAL
specific physical training program for obese childrenBEHAVIORAL

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg, Department of Internal Medicine I

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Joerg Tafel, Dr

    University Hospital Heidelberg, Department of Internal Medicine I

    PRINCIPAL INVESTIGATOR

  • Peter P Nawroth, Prof

    University Hospital Heidelberg, Department of Internal Medicine I

    STUDY CHAIR

Central Study Contacts

Joerg Tafel, Dr

CONTACT

+4962215638606Joerg_Tafel@med.uni-heidelberg.de

Peter P Nawroth, Prof

CONTACT

+496221568601Peter_Nawroth@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 26, 2007

Study Start

April 1, 2007

Last Updated

May 9, 2007

Record last verified: 2007-03

Locations

DE(1)