- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00954577
Reduce Obesity and Diabetes (ROAD)
The Pathogenesis of Type 2 Diabetes in Children and Utility of a School-based Intervention to Reduce Obesity and Diabetes in Children
This study examines risk factors for type 2 diabetes in children representing multiple discrete ethnic groups. It also examines the short term effects of school-based health education supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children. The investigators hypothesize that exercise and health education will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are:
- Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus.
- Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little effect on insulin secretory capacity in children.
- Participation in a school-based health, nutrition, and exercise education program will have long term beneficial effects on health related behaviors and on insulin resistance in all children, regardless of their level of diabetes risk.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Michael Rosenbaum, M.D.
- Telefonnummer: 212-305-9949
- E-post: mr475@columbia.edu
Studer Kontakt Backup
- Navn: Steven Shelov, M.D.
- Telefonnummer: 718-283-6150
- E-post: sshelov@maimonidesmed.org
Studiesteder
-
-
New York
-
Brooklyn, New York, Forente stater, 11219
- Rekruttering
- Maimonides Medical Center
-
Ta kontakt med:
- Deborah DeSantis, Ph.D.
- Telefonnummer: 718-283-6814
- E-post: ddesantis@maimonidesmed.org
-
Hovedetterforsker:
- Deborah DeSantis, Ph.D.
-
Manhasset, New York, Forente stater, 11030
- Rekruttering
- North Shore LIJ Schneider Children's Hospital
-
Ta kontakt med:
- Phyllis Speiser, M.D.
- Telefonnummer: 718-470-3290
- E-post: pspeiser@LIJ.edu
-
Hovedetterforsker:
- Phyllis Speiser, M.D.
-
Mineola, New York, Forente stater, 11501
- Rekruttering
- Winthrop University Hospital
-
Ta kontakt med:
- Warren Rosenfeld, M.D.
- Telefonnummer: 516-663-2288
- E-post: wrosenfeld@winthrop.org
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Hovedetterforsker:
- Warren Rosenfeld, M.D.
-
New York, New York, Forente stater, 10028
- Rekruttering
- Mt. Sinai Medical Center
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Ta kontakt med:
- Robert Rapaport, MD
- Telefonnummer: 212-241-8487
- E-post: robert.rapaport@msnyuhealth.org
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Hovedetterforsker:
- Robert Rapaport, M.D.
-
New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University Medical Center/The New York Presbyterian Hospital
-
Ta kontakt med:
- Ilene Fennoy, M.D.. M.P.H.
- Telefonnummer: 212-851-5315
- E-post: if1@columbia.edu
-
Hovedetterforsker:
- Ilene Fennoy, M.D., M.P.H.
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Children in 6th-8th grade
Exclusion Criteria:
- Diabetes
- Exercise induced asthma
- Pregnancy
- Any chronic medication that interferes with glucose homeostasis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reduction in diabetes risk factors including insulin secretory capacity, insulin sensitivity, body fat content, dyslipidemia, and circulating concentrations of pro-inflammatory cytokines.
Tidsramme: In December and May of each school year
|
In December and May of each school year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Improvement in self-esteem and in health-related behaviors.
Tidsramme: December and May of each school year
|
December and May of each school year
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Rosenbaum M, Nonas C, Horlick M, Fennoy I, Vargas I, Schachner H, Kringas P, Stanton K, Weil R; Camino Diabetes Prevention Group. beta-Cell function and insulin sensitivity in early adolescence: association with body fatness and family history of type 2 diabetes mellitus. J Clin Endocrinol Metab. 2004 Nov;89(11):5469-76. doi: 10.1210/jc.2004-0971.
- Rosenbaum M, Nonas C, Weil R, Horlick M, Fennoy I, Vargas I, Kringas P; Camino Diabetes Prevention Group. School-based intervention acutely improves insulin sensitivity and decreases inflammatory markers and body fatness in junior high school students. J Clin Endocrinol Metab. 2007 Feb;92(2):504-8. doi: 10.1210/jc.2006-1516. Epub 2006 Nov 7.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- amdecroad
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