- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00439933
Weight Loss in Obese Children and Adolescents and Its Effect on Improvement of Destructive Changes in Blood Vessels
Weight Loss in Obese Children and Adolescents and Its Effect on Improvement of Endothelial Dysfunction
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Heidelberg, Tyskland, 69120
- Rekruttering
- University Hospital Heidelberg, Department of Internal Medicine I
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Kontakt:
- Joerg Tafel, MD
- Telefonnummer: +49-6221-5638606
- E-mail: joerg_tafel@med.uni-heidelberg.de
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Ledende efterforsker:
- Jörg Tafel, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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changes in flow-mediated dilation of the brachial artery
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intima media thickness of the brachial artery
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Sekundære resultatmål
Resultatmål |
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vægttab
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Joerg Tafel, Dr, University Hospital Heidelberg, Department of Internal Medicine I
- Studiestol: Peter P Nawroth, Prof, University Hospital Heidelberg, Department of Internal Medicine I
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1-Tafel
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